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A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)

A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03448692
Acronym
PODO
Enrollment
47
Registered
2018-02-28
Start date
2018-10-15
Completion date
2023-02-14
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal Segmental Glomerulosclerosis (FSGS)

Keywords

Proteinuria

Brief summary

The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusions in adult subjects with FSGS.

Interventions

Subjects in cohort 1 will receive Dose 1 Intravenous infusion (IV). Subjects in cohort 2 will receive Dose 2 IV. Subjects in cohort 3 will receive Dose 3 IV infusion.

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

Open label

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adults age 18 years and older who have a confirmed biopsy diagnosis of FSGS. 2. Estimated glomerular filtration rate (eGFR) greater than or equal to 45 ml/min/1.73 m2. If eGFR is 30 - 45 ml/min/1.73 m2, a recent biopsy (within 12 months prior to Screening) must demonstrate \< 50% tubulointerstitial fibrosis. 3. Urine protein:creatinine ratio (UPCR) greater than 1.5 g/g at screening. 4. Treated with at least one but not more than 3 classes of immunosuppressants either alone or in combination, or has a contraindication to use of an immunosuppressant or is intolerant to an immunosuppressant per investigator judgment.

Exclusion criteria

1. Diagnosis of collapsing FSGS. 2. Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis. 3. Organ transplant. 4. History of malignancy, with the exception of basal or squamous cell carcinoma that has been treated and fully resolved for a minimum of 5 years. 5. Body mass index (BMI) greater than 45 kg/m2. 6. Subjects with a history of prior treatment with or use of interferon, lithium, pamidronate, mTOR inhibitors (eg, sirolimus), testosterone/anabolic steroids, anthracycline (eg, doxorubicin), heroin.

Design outcomes

Primary

MeasureTime frameDescription
Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) Based on 24-hour Urine Collection at Week 13Baseline, Week 13UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function.

Secondary

MeasureTime frameDescription
Number of Participants With Abnormalities in Laboratory Test ParametersFrom Day 1 of treatment up to Week 33Hemoglobin (Hg), hematocrit, erythrocytes: \<0.8\*lower limits of normal (LLN); platelets: \<0.5\*LLN\>1.75\*upper limits of normal(ULN); leukocytes (leu), glucose-fasting:\<0.6\*LLN\>1.5\*ULN; lymphocytes (lym), lym/leu, neutrophils(neu),neu/leu, protein, albumin, phosphate, free thyroxine, thyroid stimulating hormone: \<0.8\*LLN\>1.2\*ULN; basophils (bas), bas/leu, eosinophils (eos), eos/leu, monocytes(mon), mon/leu: \>1.2\*ULN; bilirubin (total, direct, indirect):\>1.5\*ULN; aspartate aminotransferase(AT), alanine AT, lactate dehydrogenase, alkaline phosphatase:\>3.0\*ULN; blood urea nitrogen, creatinine, cholesterol (total,LDL,HDL),triglycerides, Hg A1C: \>1.3\*ULN; sodium: \<0.95\*LLN\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate: \<0.9\*LLLN\>1.1\*ULN; prolactin: \>1.1\*ULN; creatine kinase: \>2.0\*ULN; urobilinogen: \>=1; Urine-specific gravity: \<1.003\>1.030, pH: \<4.5 \>8, glucose,protein,bilirubin,nitrite,leukocyte esterase, ketones: \>=1.Categories with at-least 1 non-zero values are reported.
Change From Baseline in Body WeightBaseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33Change from baseline in body weight and at baseline values were reported for this outcome measure.
Change From Baseline in Blood PressureBaseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33Change from baseline in blood pressure and at baseline values were reported for this outcome measure.
Change From Baseline in Pulse RateBaseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33Change from baseline in pulse rate and at baseline values were reported for this outcome measure.
Change From Baseline in Body TemperatureBaseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33Change from baseline in body temperature and at baseline values were reported for this outcome measure.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)From Day 1 of treatment up to 9 weeks after last dose of study treatment (up to Week 33)An adverse event was considered treatment emergent relative to a given treatment if the event occurred for the first time during the investigational treatment period and was not seen prior to the start of treatment (during the lead-in period), or the event was seen prior to the start of treatment but increased in severity during treatment. Adverse events occurring during the lead-in period were considered non-treatment emergent. Events that occurred during the follow-Up period were counted as treatment emergent and attributed to the previous treatment taken.
Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13Baseline, Weeks 2, 5, 9 and 13UPCR is a ratio between two measured substances in urine: mmol of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function.
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13Baseline, Weeks 3, 5, 9 and 13The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration, age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) = 175\*(sCr/88.4)\^-1.154\*(Age)\^-0.203\*(0.742 if female)\*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1). For Baseline eGFR, the Low eGFR group was defined as baseline eGFR \< 45 mL/min/1.73m2, and the High eGFR group was defined as baseline eGFR \> 45 mL/min/1.73 m2.
Serum PF-06730512 Concentration Versus Time SummaryFor 12-Week treatment(WT):pre-dose on Day1,8,15,29,43,57,71,follow-up(Fup)visit on Day85,99,113,141,For 24-WT:pre-dose on Day1,8,15,29,43,57,71,85,99,113,127,141,155,Fup visit on Day169,183,197,225;1hour post-dose on Day1,71,155(only applicable for 24-WT)
Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb)From Day 1 of treatment up to Week 33Number of participants with positive ADA and/or NAb were reported for this outcome measure.
Number of Participants With Abnormalities in Electrocardiogram (ECG)Weeks 3, 7, 11, 13, 17, 21, 25, 33ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcB) in millisecond (msec): greater than (\>) 450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 2) QTc interval adjusted according to Fridericia formula (QTcF) (msec): \>450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 3) Heart rate (bpm): RR decrease \>25% and to a VR (interval between QRS wave and T wave on ECG) \>100; RR (interval between 2 successive R waves on ECG) increase \>25% and to a VR \<50; 4) Pulse rate (msec): increase \>25% and to a value \>200; 5) QT (msec): \>450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 6) QRS (msec): increase \>25% and to a value \>110. Categories (timepoints) with at least 1 participant having ECG abnormality in any of the reporting arms, were reported for this outcome measure.

Countries

Canada, Czechia, France, Germany, Italy, Japan, Mexico, Poland, Slovakia, Spain, United Kingdom, United States

Participant flow

Pre-assignment details

A total of 47 participants were enrolled into the study. All participants received treatment.

Participants by arm

ArmCount
PF-06730512 1000 mg IV
Participants received PF-06730512 1000 mg IV Q2W.
23
PF-06730512 300 mg IV
Participants received PF-06730512 300 mg IV Q2W.
24
Total47

Withdrawals & dropouts

PeriodReasonFG000FG001
Investigational Treatment Period:Upto24WAdverse Event10
Investigational Treatment Period:Upto24WLack of Efficacy01
Investigational Treatment Period:Upto24WPhysician's decision01
Investigational Treatment Period:Upto24WStudy terminated by sponsor05
Investigational Treatment Period:Upto24WWithdrawal by Subject02

Baseline characteristics

CharacteristicPF-06730512 1000 mg IVPF-06730512 300 mg IVTotal
Age, Continuous42.7 Years
STANDARD_DEVIATION 13.64
41.0 Years
STANDARD_DEVIATION 14.6
41.8 Years
STANDARD_DEVIATION 14.01
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants3 Participants8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
18 Participants21 Participants39 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
3 Participants5 Participants8 Participants
Race (NIH/OMB)
Black or African American
0 Participants2 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
20 Participants16 Participants36 Participants
Sex: Female, Male
Female
12 Participants10 Participants22 Participants
Sex: Female, Male
Male
11 Participants14 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 230 / 24
other
Total, other adverse events
11 / 2312 / 24
serious
Total, serious adverse events
2 / 232 / 24

Outcome results

Primary

Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) Based on 24-hour Urine Collection at Week 13

UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function.

Time frame: Baseline, Week 13

Population: The Full Analysis Set (FAS) was defined as all enrolled participants who had received at least one dose of study treatment and had at least one post-baseline measurement of UPCR based on 24-hour urine collection. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.

ArmMeasureValue (LEAST_SQUARES_MEAN)
PF-06730512 1000 mg IVPercentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) Based on 24-hour Urine Collection at Week 13-12.283 Percentage change
PF-06730512 300 mg IVPercentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) Based on 24-hour Urine Collection at Week 13-0.045 Percentage change
Secondary

Change From Baseline in Blood Pressure

Change from baseline in blood pressure and at baseline values were reported for this outcome measure.

Time frame: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33

Population: SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.

ArmMeasureGroupValue (MEAN)Dispersion
PF-06730512 1000 mg IVChange From Baseline in Blood PressureWeek 13-2.0 Millimeter of mercury (mmHg)Standard Deviation 11.3
PF-06730512 1000 mg IVChange From Baseline in Blood PressureWeek15-7.5 Millimeter of mercury (mmHg)Standard Deviation 5.1
PF-06730512 1000 mg IVChange From Baseline in Blood PressureWeek 17-7.3 Millimeter of mercury (mmHg)Standard Deviation 12.7
PF-06730512 1000 mg IVChange From Baseline in Blood PressureWeek 19-8.0 Millimeter of mercury (mmHg)Standard Deviation 8.4
PF-06730512 1000 mg IVChange From Baseline in Blood PressureWeek 21-8.0 Millimeter of mercury (mmHg)Standard Deviation 16.4
PF-06730512 1000 mg IVChange From Baseline in Blood PressureWeek 231.0 Millimeter of mercury (mmHg)Standard Deviation 9
PF-06730512 1000 mg IVChange From Baseline in Blood PressureWeek 25-9.0 Millimeter of mercury (mmHg)Standard Deviation 13.2
PF-06730512 1000 mg IVChange From Baseline in Blood PressureWeek 27-3.0 Millimeter of mercury (mmHg)Standard Deviation 10.4
PF-06730512 1000 mg IVChange From Baseline in Blood PressureWeek 29-8.3 Millimeter of mercury (mmHg)Standard Deviation 8.4
PF-06730512 1000 mg IVChange From Baseline in Blood PressureWeek 33-12.0 Millimeter of mercury (mmHg)Standard Deviation 20.7
PF-06730512 1000 mg IVChange From Baseline in Blood PressureBaseline131.2 Millimeter of mercury (mmHg)Standard Deviation 12.8
PF-06730512 1000 mg IVChange From Baseline in Blood PressureWeek 2-1.8 Millimeter of mercury (mmHg)Standard Deviation 13.1
PF-06730512 1000 mg IVChange From Baseline in Blood PressureWeek 3-1.3 Millimeter of mercury (mmHg)Standard Deviation 10.2
PF-06730512 1000 mg IVChange From Baseline in Blood PressureWeek 5-3.0 Millimeter of mercury (mmHg)Standard Deviation 10.6
PF-06730512 1000 mg IVChange From Baseline in Blood PressureWeek 7-2.0 Millimeter of mercury (mmHg)Standard Deviation 11.3
PF-06730512 1000 mg IVChange From Baseline in Blood PressureWeek 9-5.1 Millimeter of mercury (mmHg)Standard Deviation 10.7
PF-06730512 1000 mg IVChange From Baseline in Blood PressureWeek 11-1.5 Millimeter of mercury (mmHg)Standard Deviation 12.5
PF-06730512 300 mg IVChange From Baseline in Blood PressureWeek 5-1.9 Millimeter of mercury (mmHg)Standard Deviation 9
PF-06730512 300 mg IVChange From Baseline in Blood PressureWeek 13-1.0 Millimeter of mercury (mmHg)Standard Deviation 10
PF-06730512 300 mg IVChange From Baseline in Blood PressureWeek 334.6 Millimeter of mercury (mmHg)Standard Deviation 8.9
PF-06730512 300 mg IVChange From Baseline in Blood PressureWeek15-2.3 Millimeter of mercury (mmHg)Standard Deviation 6.2
PF-06730512 300 mg IVChange From Baseline in Blood PressureWeek 21-5.8 Millimeter of mercury (mmHg)Standard Deviation 10.1
PF-06730512 300 mg IVChange From Baseline in Blood PressureWeek 17-7.7 Millimeter of mercury (mmHg)Standard Deviation 12.2
PF-06730512 300 mg IVChange From Baseline in Blood PressureBaseline125.3 Millimeter of mercury (mmHg)Standard Deviation 11.8
PF-06730512 300 mg IVChange From Baseline in Blood PressureWeek 190.4 Millimeter of mercury (mmHg)Standard Deviation 10.7
PF-06730512 300 mg IVChange From Baseline in Blood PressureWeek 7-1.2 Millimeter of mercury (mmHg)Standard Deviation 9
PF-06730512 300 mg IVChange From Baseline in Blood PressureWeek 2-1.3 Millimeter of mercury (mmHg)Standard Deviation 7.8
PF-06730512 300 mg IVChange From Baseline in Blood PressureWeek 23-3.6 Millimeter of mercury (mmHg)Standard Deviation 8.2
PF-06730512 300 mg IVChange From Baseline in Blood PressureWeek 11-1.6 Millimeter of mercury (mmHg)Standard Deviation 6.1
PF-06730512 300 mg IVChange From Baseline in Blood PressureWeek 25-2.6 Millimeter of mercury (mmHg)Standard Deviation 11.2
PF-06730512 300 mg IVChange From Baseline in Blood PressureWeek 31.7 Millimeter of mercury (mmHg)Standard Deviation 7.5
PF-06730512 300 mg IVChange From Baseline in Blood PressureWeek 273.5 Millimeter of mercury (mmHg)Standard Deviation 10.5
PF-06730512 300 mg IVChange From Baseline in Blood PressureWeek 9-2.6 Millimeter of mercury (mmHg)Standard Deviation 7.6
PF-06730512 300 mg IVChange From Baseline in Blood PressureWeek 290.4 Millimeter of mercury (mmHg)Standard Deviation 11.2
Secondary

Change From Baseline in Body Temperature

Change from baseline in body temperature and at baseline values were reported for this outcome measure.

Time frame: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33

Population: SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.

ArmMeasureGroupValue (MEAN)Dispersion
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureWeek 20.1 Degree CelsiusStandard Deviation 0.4
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureWeek 170.1 Degree CelsiusStandard Deviation 0.2
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureWeek 90.0 Degree CelsiusStandard Deviation 0.4
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureWeek 190.1 Degree CelsiusStandard Deviation 0.4
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureWeek 50.0 Degree CelsiusStandard Deviation 0.4
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureWeek 21-0.0 Degree CelsiusStandard Deviation 0.1
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureWeek 110.1 Degree CelsiusStandard Deviation 0.3
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureWeek 230.2 Degree CelsiusStandard Deviation 0.2
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureWeek 30.0 Degree CelsiusStandard Deviation 0.2
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureWeek 250.1 Degree CelsiusStandard Deviation 0.2
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureWeek 13-0.1 Degree CelsiusStandard Deviation 0.4
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureWeek 270.1 Degree CelsiusStandard Deviation 0.1
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureWeek 70.1 Degree CelsiusStandard Deviation 0.3
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureWeek 290.1 Degree CelsiusStandard Deviation 0.3
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureWeek 150.2 Degree CelsiusStandard Deviation 0.2
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureWeek 330.1 Degree CelsiusStandard Deviation 0.1
PF-06730512 1000 mg IVChange From Baseline in Body TemperatureBaseline36.4 Degree CelsiusStandard Deviation 0.4
PF-06730512 300 mg IVChange From Baseline in Body TemperatureWeek 33-0.1 Degree CelsiusStandard Deviation 0.3
PF-06730512 300 mg IVChange From Baseline in Body TemperatureBaseline36.6 Degree CelsiusStandard Deviation 0.2
PF-06730512 300 mg IVChange From Baseline in Body TemperatureWeek 2-0.0 Degree CelsiusStandard Deviation 0.3
PF-06730512 300 mg IVChange From Baseline in Body TemperatureWeek 3-0.1 Degree CelsiusStandard Deviation 0.3
PF-06730512 300 mg IVChange From Baseline in Body TemperatureWeek 5-0.1 Degree CelsiusStandard Deviation 0.3
PF-06730512 300 mg IVChange From Baseline in Body TemperatureWeek 7-0.0 Degree CelsiusStandard Deviation 0.3
PF-06730512 300 mg IVChange From Baseline in Body TemperatureWeek 9-0.1 Degree CelsiusStandard Deviation 0.3
PF-06730512 300 mg IVChange From Baseline in Body TemperatureWeek 11-0.0 Degree CelsiusStandard Deviation 0.3
PF-06730512 300 mg IVChange From Baseline in Body TemperatureWeek 13-0.0 Degree CelsiusStandard Deviation 0.2
PF-06730512 300 mg IVChange From Baseline in Body TemperatureWeek 150.1 Degree CelsiusStandard Deviation 0.2
PF-06730512 300 mg IVChange From Baseline in Body TemperatureWeek 170.1 Degree CelsiusStandard Deviation 0.2
PF-06730512 300 mg IVChange From Baseline in Body TemperatureWeek 190.1 Degree CelsiusStandard Deviation 0.3
PF-06730512 300 mg IVChange From Baseline in Body TemperatureWeek 21-0.1 Degree CelsiusStandard Deviation 0.5
PF-06730512 300 mg IVChange From Baseline in Body TemperatureWeek 230.0 Degree CelsiusStandard Deviation 0.3
PF-06730512 300 mg IVChange From Baseline in Body TemperatureWeek 250.0 Degree CelsiusStandard Deviation 0.2
PF-06730512 300 mg IVChange From Baseline in Body TemperatureWeek 270.1 Degree CelsiusStandard Deviation 0.2
PF-06730512 300 mg IVChange From Baseline in Body TemperatureWeek 29-0.1 Degree CelsiusStandard Deviation 0.4
Secondary

Change From Baseline in Body Weight

Change from baseline in body weight and at baseline values were reported for this outcome measure.

Time frame: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33

Population: SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.

ArmMeasureGroupValue (MEAN)Dispersion
PF-06730512 1000 mg IVChange From Baseline in Body WeightWeek 270.7 KilogramStandard Deviation 1.4
PF-06730512 1000 mg IVChange From Baseline in Body WeightBaseline78.3 KilogramStandard Deviation 17.8
PF-06730512 1000 mg IVChange From Baseline in Body WeightWeek 21.0 KilogramStandard Deviation 2.2
PF-06730512 1000 mg IVChange From Baseline in Body WeightWeek 30.4 KilogramStandard Deviation 2.5
PF-06730512 1000 mg IVChange From Baseline in Body WeightWeek 50.5 KilogramStandard Deviation 3
PF-06730512 1000 mg IVChange From Baseline in Body WeightWeek 70.6 KilogramStandard Deviation 2.6
PF-06730512 1000 mg IVChange From Baseline in Body WeightWeek 90.1 KilogramStandard Deviation 3.1
PF-06730512 1000 mg IVChange From Baseline in Body WeightWeek 110.7 KilogramStandard Deviation 2.8
PF-06730512 1000 mg IVChange From Baseline in Body WeightWeek 13-0.2 KilogramStandard Deviation 1.9
PF-06730512 1000 mg IVChange From Baseline in Body WeightWeek15-0.3 KilogramStandard Deviation 1
PF-06730512 1000 mg IVChange From Baseline in Body WeightWeek 17-0.2 KilogramStandard Deviation 1.2
PF-06730512 1000 mg IVChange From Baseline in Body WeightWeek 19-0.4 KilogramStandard Deviation 1
PF-06730512 1000 mg IVChange From Baseline in Body WeightWeek 210.3 KilogramStandard Deviation 1.7
PF-06730512 1000 mg IVChange From Baseline in Body WeightWeek 230.3 KilogramStandard Deviation 1.2
PF-06730512 1000 mg IVChange From Baseline in Body WeightWeek 25-0.1 KilogramStandard Deviation 1.6
PF-06730512 1000 mg IVChange From Baseline in Body WeightWeek 290.5 KilogramStandard Deviation 1.5
PF-06730512 1000 mg IVChange From Baseline in Body WeightWeek 330.5 KilogramStandard Deviation 1.6
PF-06730512 300 mg IVChange From Baseline in Body WeightWeek 23-1.5 KilogramStandard Deviation 5.3
PF-06730512 300 mg IVChange From Baseline in Body WeightWeek15-0.7 KilogramStandard Deviation 4
PF-06730512 300 mg IVChange From Baseline in Body WeightBaseline88.9 KilogramStandard Deviation 23.5
PF-06730512 300 mg IVChange From Baseline in Body WeightWeek 29-1.0 KilogramStandard Deviation 4.5
PF-06730512 300 mg IVChange From Baseline in Body WeightWeek 2-0.3 KilogramStandard Deviation 1.9
PF-06730512 300 mg IVChange From Baseline in Body WeightWeek 17-1.2 KilogramStandard Deviation 4.8
PF-06730512 300 mg IVChange From Baseline in Body WeightWeek 3-0.3 KilogramStandard Deviation 2.2
PF-06730512 300 mg IVChange From Baseline in Body WeightWeek 25-1.1 KilogramStandard Deviation 4.8
PF-06730512 300 mg IVChange From Baseline in Body WeightWeek 5-0.5 KilogramStandard Deviation 4.8
PF-06730512 300 mg IVChange From Baseline in Body WeightWeek 19-1.3 KilogramStandard Deviation 4.8
PF-06730512 300 mg IVChange From Baseline in Body WeightWeek 7-1.0 KilogramStandard Deviation 5.3
PF-06730512 300 mg IVChange From Baseline in Body WeightWeek 27-0.6 KilogramStandard Deviation 5.2
PF-06730512 300 mg IVChange From Baseline in Body WeightWeek 9-0.4 KilogramStandard Deviation 3.4
PF-06730512 300 mg IVChange From Baseline in Body WeightWeek 21-1.3 KilogramStandard Deviation 4.9
PF-06730512 300 mg IVChange From Baseline in Body WeightWeek 11-0.1 KilogramStandard Deviation 4.2
PF-06730512 300 mg IVChange From Baseline in Body WeightWeek 33-0.6 KilogramStandard Deviation 5.4
PF-06730512 300 mg IVChange From Baseline in Body WeightWeek 13-1.0 KilogramStandard Deviation 3.4
Secondary

Change From Baseline in Pulse Rate

Change from baseline in pulse rate and at baseline values were reported for this outcome measure.

Time frame: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33

Population: SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.

ArmMeasureGroupValue (MEAN)Dispersion
PF-06730512 1000 mg IVChange From Baseline in Pulse RateWeek 22.1 Beats per minuteStandard Deviation 9.6
PF-06730512 1000 mg IVChange From Baseline in Pulse RateWeek 17-6.3 Beats per minuteStandard Deviation 8.8
PF-06730512 1000 mg IVChange From Baseline in Pulse RateWeek 9-1.0 Beats per minuteStandard Deviation 11.1
PF-06730512 1000 mg IVChange From Baseline in Pulse RateWeek 19-3.5 Beats per minuteStandard Deviation 13.7
PF-06730512 1000 mg IVChange From Baseline in Pulse RateWeek 50.0 Beats per minuteStandard Deviation 7.3
PF-06730512 1000 mg IVChange From Baseline in Pulse RateWeek 21-5.5 Beats per minuteStandard Deviation 12.8
PF-06730512 1000 mg IVChange From Baseline in Pulse RateWeek 11-1.7 Beats per minuteStandard Deviation 10.8
PF-06730512 1000 mg IVChange From Baseline in Pulse RateWeek 23-3.3 Beats per minuteStandard Deviation 10.5
PF-06730512 1000 mg IVChange From Baseline in Pulse RateWeek 3-0.6 Beats per minuteStandard Deviation 8
PF-06730512 1000 mg IVChange From Baseline in Pulse RateWeek 25-6.3 Beats per minuteStandard Deviation 12.5
PF-06730512 1000 mg IVChange From Baseline in Pulse RateWeek 133.3 Beats per minuteStandard Deviation 11.9
PF-06730512 1000 mg IVChange From Baseline in Pulse RateWeek 27-0.8 Beats per minuteStandard Deviation 16
PF-06730512 1000 mg IVChange From Baseline in Pulse RateWeek 7-0.3 Beats per minuteStandard Deviation 9.2
PF-06730512 1000 mg IVChange From Baseline in Pulse RateWeek 292.5 Beats per minuteStandard Deviation 14.8
PF-06730512 1000 mg IVChange From Baseline in Pulse RateWeek15-5.8 Beats per minuteStandard Deviation 10.4
PF-06730512 1000 mg IVChange From Baseline in Pulse RateWeek 33-0.5 Beats per minuteStandard Deviation 15.3
PF-06730512 1000 mg IVChange From Baseline in Pulse RateBaseline74.1 Beats per minuteStandard Deviation 11.8
PF-06730512 300 mg IVChange From Baseline in Pulse RateWeek 336.2 Beats per minuteStandard Deviation 10
PF-06730512 300 mg IVChange From Baseline in Pulse RateBaseline74.2 Beats per minuteStandard Deviation 11
PF-06730512 300 mg IVChange From Baseline in Pulse RateWeek 20.6 Beats per minuteStandard Deviation 6.9
PF-06730512 300 mg IVChange From Baseline in Pulse RateWeek 3-1.1 Beats per minuteStandard Deviation 6
PF-06730512 300 mg IVChange From Baseline in Pulse RateWeek 5-0.3 Beats per minuteStandard Deviation 8
PF-06730512 300 mg IVChange From Baseline in Pulse RateWeek 70.0 Beats per minuteStandard Deviation 7.9
PF-06730512 300 mg IVChange From Baseline in Pulse RateWeek 91.5 Beats per minuteStandard Deviation 9
PF-06730512 300 mg IVChange From Baseline in Pulse RateWeek 110.6 Beats per minuteStandard Deviation 6.6
PF-06730512 300 mg IVChange From Baseline in Pulse RateWeek 130.5 Beats per minuteStandard Deviation 6.9
PF-06730512 300 mg IVChange From Baseline in Pulse RateWeek155.0 Beats per minuteStandard Deviation 10.1
PF-06730512 300 mg IVChange From Baseline in Pulse RateWeek 17-2.2 Beats per minuteStandard Deviation 5
PF-06730512 300 mg IVChange From Baseline in Pulse RateWeek 192.9 Beats per minuteStandard Deviation 6.5
PF-06730512 300 mg IVChange From Baseline in Pulse RateWeek 21-1.6 Beats per minuteStandard Deviation 5
PF-06730512 300 mg IVChange From Baseline in Pulse RateWeek 23-3.1 Beats per minuteStandard Deviation 9
PF-06730512 300 mg IVChange From Baseline in Pulse RateWeek 251.8 Beats per minuteStandard Deviation 7.6
PF-06730512 300 mg IVChange From Baseline in Pulse RateWeek 272.9 Beats per minuteStandard Deviation 7.2
PF-06730512 300 mg IVChange From Baseline in Pulse RateWeek 295.9 Beats per minuteStandard Deviation 8.8
Secondary

Number of Participants With Abnormalities in Electrocardiogram (ECG)

ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcB) in millisecond (msec): greater than (\>) 450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 2) QTc interval adjusted according to Fridericia formula (QTcF) (msec): \>450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 3) Heart rate (bpm): RR decrease \>25% and to a VR (interval between QRS wave and T wave on ECG) \>100; RR (interval between 2 successive R waves on ECG) increase \>25% and to a VR \<50; 4) Pulse rate (msec): increase \>25% and to a value \>200; 5) QT (msec): \>450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 6) QRS (msec): increase \>25% and to a value \>110. Categories (timepoints) with at least 1 participant having ECG abnormality in any of the reporting arms, were reported for this outcome measure.

Time frame: Weeks 3, 7, 11, 13, 17, 21, 25, 33

Population: SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 3 (Not Clinically Significant)3 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 3 (Clinically Significant)1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 7 (Not Clinically Significant)3 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 7 (Clinically Significant)0 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 11 (Not Clinically Significant)4 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 11 (Clinically Significant)1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 13 (Not Clinically Significant)6 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 13 (Clinically Significant)1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 17 (Not Clinically Significant)0 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 17 (Clinically Significant)0 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 21 (Not Clinically Significant)1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 21 (Clinically Significant)0 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 25 (Not Clinically Significant)1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 25 (Clinically Significant)0 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 33 (Not Clinically Significant)0 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 33 (Clinically Significant)0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 33 (Clinically Significant)0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 3 (Not Clinically Significant)4 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 17 (Not Clinically Significant)0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 3 (Clinically Significant)0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 25 (Not Clinically Significant)1 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 7 (Not Clinically Significant)4 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 17 (Clinically Significant)0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 7 (Clinically Significant)0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 33 (Not Clinically Significant)2 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 11 (Not Clinically Significant)4 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 21 (Not Clinically Significant)1 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 11 (Clinically Significant)0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 25 (Clinically Significant)0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 13 (Not Clinically Significant)4 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 21 (Clinically Significant)0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Electrocardiogram (ECG)Week 13 (Clinically Significant)0 Participants
Secondary

Number of Participants With Abnormalities in Laboratory Test Parameters

Hemoglobin (Hg), hematocrit, erythrocytes: \<0.8\*lower limits of normal (LLN); platelets: \<0.5\*LLN\>1.75\*upper limits of normal(ULN); leukocytes (leu), glucose-fasting:\<0.6\*LLN\>1.5\*ULN; lymphocytes (lym), lym/leu, neutrophils(neu),neu/leu, protein, albumin, phosphate, free thyroxine, thyroid stimulating hormone: \<0.8\*LLN\>1.2\*ULN; basophils (bas), bas/leu, eosinophils (eos), eos/leu, monocytes(mon), mon/leu: \>1.2\*ULN; bilirubin (total, direct, indirect):\>1.5\*ULN; aspartate aminotransferase(AT), alanine AT, lactate dehydrogenase, alkaline phosphatase:\>3.0\*ULN; blood urea nitrogen, creatinine, cholesterol (total,LDL,HDL),triglycerides, Hg A1C: \>1.3\*ULN; sodium: \<0.95\*LLN\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate: \<0.9\*LLLN\>1.1\*ULN; prolactin: \>1.1\*ULN; creatine kinase: \>2.0\*ULN; urobilinogen: \>=1; Urine-specific gravity: \<1.003\>1.030, pH: \<4.5 \>8, glucose,protein,bilirubin,nitrite,leukocyte esterase, ketones: \>=1.Categories with at-least 1 non-zero values are reported.

Time frame: From Day 1 of treatment up to Week 33

Population: SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Hemoglobin < 0.8 * Lower Limit Number (LLN)5 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Hematocrit < 0.8 * LLN5 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Ery. Mean Corpuscular Volume < 0.9 * LLN1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Ery. Mean Corpuscular Hemoglobin < 0.9 * LLN1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Erythrocytes < 0.8 * LLN3 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Platelets> 1.75 * ULN1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Lymphocytes< 0.8 * LLN0 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Lymphocytes/Leukocytes < 0.8 * LLN1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Lymphocytes/Leukocytes > 1.2 * ULN0 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Neutrophils < 0.8 * LLN1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Neutrophils > 1.2 * ULN3 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Neutrophils/Leukocytes < 0.8 * LLN1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Neutrophils/Leukocytes > 1.2 * ULN0 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Eosinophils > 1.2 * ULN2 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Eosinophils/Leukocytes> 1.2 * ULN3 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Monocytes/Leukocytes> 1.2 * ULN0 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Aspartate Aminotransferase > 3.0 * ULN1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Alanine Aminotransferase > 3.0 * ULN1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Protein < 0.8 * LLN9 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Albumin < 0.8 * LLN8 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Blood Urea Nitrogen > 1.3 * ULN10 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Creatinine > 1.3 * ULN8 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Urate > 1.2 * ULN3 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Cholesterol > 1.3 * ULN6 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: HDL Cholesterol < 0.8 * LLN1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: LDL Cholesterol > 1.2 * ULN6 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Triglycerides > 1.3 * ULN6 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Sodium < 0.95 * LLN1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Potassium < 0.9 * LLN1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Potassium > 1.1 * ULN1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Calcium < 0.9 * LLN1 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Bicarbonate < 0.9 * LLN0 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Glucose > 1.5 * ULN2 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Specific Gravity > 1.0305 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: pH > 81 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Urine Glucose >= 15 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Urine Protein >=122 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Urine Hemoglobin >=115 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Nitrite >= 11 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Leukocyte Esterase >= 15 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Urine Erythrocytes >= 203 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Urine Leukocytes >= 202 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Granular Casts > 14 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Hyaline Casts > 117 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Urine Creatinine <409 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Urine Creatinine >3001 Participants
PF-06730512 1000 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Urine (24HR) Creatinine > 1.1 * ULN2 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Cholesterol > 1.3 * ULN7 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Hemoglobin < 0.8 * Lower Limit Number (LLN)4 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Urine Glucose >= 110 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Hematocrit < 0.8 * LLN7 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Erythrocytes < 0.8 * LLN4 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: HDL Cholesterol < 0.8 * LLN0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Ery. Mean Corpuscular Volume < 0.9 * LLN0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Urine Leukocytes >= 205 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Ery. Mean Corpuscular Hemoglobin < 0.9 * LLN0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: LDL Cholesterol > 1.2 * ULN5 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Urine Protein >=124 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Platelets> 1.75 * ULN0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Triglycerides > 1.3 * ULN8 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Lymphocytes< 0.8 * LLN4 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Urine Creatinine <408 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Lymphocytes/Leukocytes < 0.8 * LLN6 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Sodium < 0.95 * LLN0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Lymphocytes/Leukocytes > 1.2 * ULN1 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Urine Hemoglobin >=117 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Neutrophils < 0.8 * LLN2 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Potassium < 0.9 * LLN0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Neutrophils > 1.2 * ULN4 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Granular Casts > 12 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Neutrophils/Leukocytes < 0.8 * LLN1 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Potassium > 1.1 * ULN0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Neutrophils/Leukocytes > 1.2 * ULN1 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Nitrite >= 13 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Eosinophils > 1.2 * ULN1 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Calcium < 0.9 * LLN3 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Eosinophils/Leukocytes> 1.2 * ULN3 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Urine (24HR) Creatinine > 1.1 * ULN6 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersHematology: Monocytes/Leukocytes> 1.2 * ULN1 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Bicarbonate < 0.9 * LLN1 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Aspartate Aminotransferase > 3.0 * ULN0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Leukocyte Esterase >= 16 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Alanine Aminotransferase > 3.0 * ULN0 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Glucose > 1.5 * ULN2 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Protein < 0.8 * LLN11 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Hyaline Casts > 115 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Albumin < 0.8 * LLN11 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Specific Gravity > 1.0306 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Blood Urea Nitrogen > 1.3 * ULN8 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Urine Erythrocytes >= 203 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Creatinine > 1.3 * ULN12 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: pH > 80 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersClinical chemistry: Urate > 1.2 * ULN2 Participants
PF-06730512 300 mg IVNumber of Participants With Abnormalities in Laboratory Test ParametersUrinalysis: Urine Creatinine >3000 Participants
Secondary

Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb)

Number of participants with positive ADA and/or NAb were reported for this outcome measure.

Time frame: From Day 1 of treatment up to Week 33

Population: The immunogenicity analysis population included all treated participants with at least 1 ADA sample (pre-dose or post-treatment) analyzed. Participants those had only pre-dose baseline data and no post-treatment immunogenicity data, was not evaluated for subject-level ADA and NAb status. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-06730512 1000 mg IVNumber of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb)ADA Positive1 Participants
PF-06730512 1000 mg IVNumber of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb)nAb Positive0 Participants
PF-06730512 300 mg IVNumber of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb)ADA Positive0 Participants
PF-06730512 300 mg IVNumber of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb)nAb Positive0 Participants
Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

An adverse event was considered treatment emergent relative to a given treatment if the event occurred for the first time during the investigational treatment period and was not seen prior to the start of treatment (during the lead-in period), or the event was seen prior to the start of treatment but increased in severity during treatment. Adverse events occurring during the lead-in period were considered non-treatment emergent. Events that occurred during the follow-Up period were counted as treatment emergent and attributed to the previous treatment taken.

Time frame: From Day 1 of treatment up to 9 weeks after last dose of study treatment (up to Week 33)

Population: SAS was defined as all enrolled participants who had received at least one dose of study treatment.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PF-06730512 1000 mg IVNumber of Participants With Treatment Emergent Adverse Events (TEAEs)20 Participants
PF-06730512 300 mg IVNumber of Participants With Treatment Emergent Adverse Events (TEAEs)17 Participants
Secondary

Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13

The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration, age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) = 175\*(sCr/88.4)\^-1.154\*(Age)\^-0.203\*(0.742 if female)\*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1). For Baseline eGFR, the Low eGFR group was defined as baseline eGFR \< 45 mL/min/1.73m2, and the High eGFR group was defined as baseline eGFR \> 45 mL/min/1.73 m2.

Time frame: Baseline, Weeks 3, 5, 9 and 13

Population: FAS was defined as all enrolled subjects who had received at least one dose of study treatment and had at least one post-baseline measurement of UPCR based on 24-hour urine collected. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-06730512 1000 mg IVPercentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13Week 35.657 Percent change
PF-06730512 1000 mg IVPercentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13Week 52.174 Percent change
PF-06730512 1000 mg IVPercentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13Week 9-1.536 Percent change
PF-06730512 1000 mg IVPercentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13Week 132.892 Percent change
PF-06730512 300 mg IVPercentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13Week 13-12.217 Percent change
PF-06730512 300 mg IVPercentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13Week 3-0.180 Percent change
PF-06730512 300 mg IVPercentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13Week 9-5.017 Percent change
PF-06730512 300 mg IVPercentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13Week 5-2.038 Percent change
Secondary

Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13

UPCR is a ratio between two measured substances in urine: mmol of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function.

Time frame: Baseline, Weeks 2, 5, 9 and 13

Population: FAS was defined as all enrolled subjects who had received at least one dose of study treatment and had at least one post-baseline measurement of UPCR based on 24-hour urine collected. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-06730512 1000 mg IVPercentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13Week 13-12.283 Percent change
PF-06730512 1000 mg IVPercentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13Week 9-11.335 Percent change
PF-06730512 1000 mg IVPercentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13Week 56.250 Percent change
PF-06730512 300 mg IVPercentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13Week 5-3.788 Percent change
PF-06730512 300 mg IVPercentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13Week 13-0.045 Percent change
PF-06730512 300 mg IVPercentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13Week 9-2.354 Percent change
UnknownPercentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13Week 2 Percent change
Secondary

Serum PF-06730512 Concentration Versus Time Summary

Time frame: For 12-Week treatment(WT):pre-dose on Day1,8,15,29,43,57,71,follow-up(Fup)visit on Day85,99,113,141,For 24-WT:pre-dose on Day1,8,15,29,43,57,71,85,99,113,127,141,155,Fup visit on Day169,183,197,225;1hour post-dose on Day1,71,155(only applicable for 24-WT)

Population: The PK concentration analysis set was defined as all enrolled participants treated who received at least one dose of PF-06730512 and had at least 1 measurable concentration. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.

ArmMeasureGroupValue (MEAN)Dispersion
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 141: Pre-dose (24WT)38.00 Microgram per milliliterStandard Deviation 13.88
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 1: Post-dose (12,24WT)279.4 Microgram per milliliterStandard Deviation 86.548
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 8: Pre-dose (12,24WT)39.50 Microgram per milliliter
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 15: Pre-dose (12,24WT)16.45 Microgram per milliliterStandard Deviation 11.266
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 29: Pre-dose (12,24WT)24.92 Microgram per milliliterStandard Deviation 20.256
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 43: Pre-dose (12,24WT)29.96 Microgram per milliliterStandard Deviation 22.062
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 57: Pre-dose (12,24WT)32.56 Microgram per milliliterStandard Deviation 23.031
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 71: Pre-dose (12,24WT)27.32 Microgram per milliliterStandard Deviation 16.688
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 71: Post-dose(12,24WT)298.6 Microgram per milliliterStandard Deviation 208.87
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 85: Pre-dose (24WT)41.15 Microgram per milliliterStandard Deviation 23.516
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 85/Fup (12 WT)27.19 Microgram per milliliterStandard Deviation 21.589
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 99/Fup (12 WT)11.50 Microgram per milliliterStandard Deviation 12.948
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 113/Fup (12 WT)4.991 Microgram per milliliterStandard Deviation 6.1121
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 141/Fup (12 WT)1.385 Microgram per milliliterStandard Deviation 2.1196
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 99: Pre-dose (24WT)35.65 Microgram per milliliterStandard Deviation 16.065
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 113: Pre-dose (24WT)42.40 Microgram per milliliterStandard Deviation 25.049
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 127: Pre-dose (24WT)30.67 Microgram per milliliterStandard Deviation 5.3463
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 1: Pre-dose (12,24WT)0 Microgram per milliliterStandard Deviation 0
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 155: Post-dose (24WT)313.3 Microgram per milliliterStandard Deviation 63.793
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 169: Pre-dose/Fup (24WT)29.32 Microgram per milliliterStandard Deviation 15.338
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 183/Fup (24WT)25.79 Microgram per milliliterStandard Deviation 30.417
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 197/Fup (24WT)6.108 Microgram per milliliterStandard Deviation 4.0049
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 225/Fup (24WT)2.009 Microgram per milliliterStandard Deviation 1.6808
PF-06730512 1000 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 155: Pre-dose (24WT)32.57 Microgram per milliliterStandard Deviation 5.8287
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 141: Pre-dose (24WT)8.957 Microgram per milliliterStandard Deviation 10.753
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 1: Pre-dose (12,24WT)0 Microgram per milliliterStandard Deviation 0
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 113/Fup (12 WT)0.6356 Microgram per milliliterStandard Deviation 0.81118
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 1: Post-dose (12,24WT)71.94 Microgram per milliliterStandard Deviation 29.668
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 197/Fup (24WT)1.048 Microgram per milliliterStandard Deviation 1.4978
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 8: Pre-dose (12,24WT)13.09 Microgram per milliliterStandard Deviation 6.9363
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 155: Pre-dose (24WT)7.585 Microgram per milliliterStandard Deviation 8.1601
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 15: Pre-dose (12,24WT)5.096 Microgram per milliliterStandard Deviation 3.1184
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 141/Fup (12 WT)0.1438 Microgram per milliliterStandard Deviation 0.21666
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 29: Pre-dose (12,24WT)6.916 Microgram per milliliterStandard Deviation 5.0154
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 225/Fup (24WT)0.2659 Microgram per milliliterStandard Deviation 0.45714
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 43: Pre-dose (12,24WT)6.991 Microgram per milliliterStandard Deviation 5.5862
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 99: Pre-dose (24WT)7.084 Microgram per milliliterStandard Deviation 6.9224
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 57: Pre-dose (12,24WT)7.664 Microgram per milliliterStandard Deviation 6.1325
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 155: Post-dose (24WT)62.71 Microgram per milliliterStandard Deviation 41.324
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 71: Pre-dose (12,24WT)6.736 Microgram per milliliterStandard Deviation 5.6237
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 113: Pre-dose (24WT)9.442 Microgram per milliliterStandard Deviation 8.6965
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 71: Post-dose(12,24WT)129.2 Microgram per milliliterStandard Deviation 201.5
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 183/Fup (24WT)3.046 Microgram per milliliterStandard Deviation 3.8895
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 85: Pre-dose (24WT)7.597 Microgram per milliliterStandard Deviation 6.9184
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 127: Pre-dose (24WT)6.732 Microgram per milliliterStandard Deviation 5.2295
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 85/Fup (12 WT)6.884 Microgram per milliliterStandard Deviation 7.1511
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 169: Pre-dose/Fup (24WT)7.989 Microgram per milliliterStandard Deviation 7.474
PF-06730512 300 mg IVSerum PF-06730512 Concentration Versus Time SummaryDay 99/Fup (12 WT)2.313 Microgram per milliliterStandard Deviation 3.1827

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026