End-stage Renal Disease, Hyperphosphatemia, Renal Failure Chronic Requiring Hemodialysis
Conditions
Keywords
hyperphosphatemia, end-stage renal disease, ESRD, hemodialysis, diabetes, dialysis
Brief summary
The objective of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a dietary phosphate binder in controlling and managing serum phosphorus levels in patients with end-stage renal disease (ESRD).
Detailed description
This is a multi-center, non-blinded, efficacy and tolerability trial in patients with ESRD on dialysis three times per week. Approximately 24 patients (approximately twelve diabetic patients and approximately twelve non-diabetic patients) in Israel will be initiated on KRX-0502 (ferric citrate). The study will consist of a two-week washout period immediately followed by a six-week treatment period in. Patients will be initiated on study drug over two to three weeks.
Interventions
DRUGferric citrate
KRX-0502 will be supplied as one caplet of ferric citrate containing 210 mg of ferric iron as ferric citrate
Sponsors
Keryx Biopharmaceuticals
Study design
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and non-pregnant, non-lactating females 2. Age \> 18 years 3. On thrice weekly hemodialysis for at least the previous three months prior to screening 4. Serum phosphorus levels ≥ 2.5 mg/dL and \< 8.5 mg/dL at Screening Visit (Visit 0) 5. Serum phosphorus levels \> 5.5 mg/dL at Study Drug Initiation Visit (Visit 3) 6. Taking 3 to 18 tablets/capsules/day of calcium acetate calcium carbonate, lanthanum carbonate, sevelamer (hydrochloride or carbonate), or any combination of these agents as reported by the patient at screening 7. Serum ferritin \<1000micrograms/L and Transferrin Saturation (TSAT) \<50% 8. Willing to be discontinued from current phosphate binder(s) and initiated on KRX-0502 (ferric citrate) 9. Willing and able to give informed consent
Exclusion criteria
1. Parathyroidectomy within six months prior to Screening Visit (Visit 0) 2. Actively symptomatic gastrointestinal bleeding and inflammatory bowel disease 3. Serum phosphorus levels \>10.0 mg/dL documented in the three monthly laboratories (done routinely in the dialysis unit) in the three months prior to the Screening Visit (Visit 0) 4. History of multiple drug allergies 5. History of malignancy in the last five years (treated cervical or skin cancer may be permitted if approved by Keryx) 6. Previous intolerance to oral ferric citrate 7. Absolute requirement for oral iron therapy 8. Absolute requirement for Vitamin C (multivitamins \[Centrum, Nephrocaps, Renaphro, etc.\] allowed) 9. Absolute requirement for calcium, magnesium, or aluminum containing drugs with meals 10. Psychiatric disorder that interferes with the patient's ability to comply with the study protocol 11. Inability to tolerate oral drug intake 12. Planned surgery or hospitalization during the study (scheduled outpatient access surgery allowed) 13. Any other medical condition that renders the patient unable to or unlikely to complete the study or that would interfere with optimal participation in the study or produce significant risk to the patient 14. Receipt of any investigational drug within 30 days of randomization 15. Inability to cooperate with study personnel or history of noncompliance 16. Prior exposure to ferric citrate 17. Patients with hemochromatosis or Thalassemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Outcome of This Trial Will be the Change in Serum Phosphorus From Baseline to End of Treatment After a Four Week Treatment Period. | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The Incidence of Treatment-emergent Adverse Events (New or Worsened From Study Drug Initiation) Will be Summarized by Body System, Severity, Type of Adverse Event, and Presumed Relationship to the Study Drug. | 6 weeks |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| KRX-0502 All subjects in this group will receive treatment with KRX-0502, 1g ferric citrate containing approximately 210 mg of ferric iron | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | KRX-0502 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 0.8 |
| Region of Enrollment Israel | 22 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
The Primary Outcome of This Trial Will be the Change in Serum Phosphorus From Baseline to End of Treatment After a Four Week Treatment Period.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KRX-0502 (Ferric Citrate) | The Primary Outcome of This Trial Will be the Change in Serum Phosphorus From Baseline to End of Treatment After a Four Week Treatment Period. | -1.53 mg/dL | Standard Deviation 1.22 |
Secondary
The Incidence of Treatment-emergent Adverse Events (New or Worsened From Study Drug Initiation) Will be Summarized by Body System, Severity, Type of Adverse Event, and Presumed Relationship to the Study Drug.
Time frame: 6 weeks