Renal Impairment
Conditions
Keywords
Renal Impairment, Kidney Impairment, Kidney Disease, Ferriprox, Deferiprone, DFP (deferiprone), L1
Brief summary
Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired renal function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg Ferriprox®.
Detailed description
Post-marketing study to evaluate the effect of impaired renal function on the pharmacokinetics (PK) of deferiprone and its 3-O-glucuronide metabolite and on the safety of Ferriprox® in subjects with mild, moderate and severe renal impairment as compared to healthy volunteers.
Interventions
DRUGDeferiprone
Oral iron chelator
Sponsors
ApoPharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Main Inclusion Criteria: All subjects: 1. Adult males or females, 18 - 75 years of age (inclusive); 2. Body weight ≥ 45 kg; 3. Body mass index (BMI) range of approximately 18.5-32 kg/m\^2 (inclusive); 4. Absolute neutrophil count (ANC) of \>1.5x10\^9/L; Healthy volunteers: 1. Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, vital signs, physical examination); 2. eGFR ≥ 90 mL/min/1.73m\^2; Renally impaired subjects: 1. Considered clinically stable in the opinion of the Investigator; 2. Subjects with mild renal impairment (eGFR 60-89 mL/min/1.73m\^E2) OR moderate renal impairment (eGFR 30-59 mL/min/1.73m\^2) OR severe renal impairment (eGFR 15-29 mL/min/1.73m\^2). Main
Exclusion criteria
1. History of renal transplant; 2. Subjects undergoing any method of dialysis; 3. History or presence of clinically unstable significant respiratory, cardiovascular, pulmonary, hepatic, renal (except for subjects assigned to one of the renally impaired groups), hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease; 4. Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the PK of the investigational medicinal product (e.g. cholecystectomy, resections of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, endocrine disease, severe infections, acute inflammations, etc.); 5. Clinically significant abnormalities on 12-lead ECG (e.g., QTcF≥430 ms in males or ≥450 ms in females); 6. Evidence of liver damage: hepatitis B and C; aspartate aminotransferase (AST), alanine aminotransferase (ALT) that is considered clinically significant by the Investigator; 7. Participation in another clinical trial within 28 days prior to the study drug administration;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | 24-hour interval | Cmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal, mild, moderate and severe renal impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose. |
| Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | 24 hour interval | Tmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose. The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation). |
| AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide | 24 hour interval | AUC0-∞ was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose. |
| T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide | 24 hour interval | T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose. |
| Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide | 24 hour interval | Ae24 (the amount excreted in urine from time zero to 24 hours) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Urine samples were collected at the intervals of -2 to 0 hours pre-dose and 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24 hours post-dose. |
| Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide | 24-hour interval | Fe24 (fraction of dose excreted in urine from time zero to 24 hours) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Urine samples were collected at the intervals of -2 to 0 hours pre-dose and 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24 hours post-dose. Some of the Fe24 values were over 100% which could be explained by variability in urine collection (e.g. incomplete collection of urine into the container) and volume measurement, as well as analytical imprecision. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Ferriprox® in Subjects With Renal Impairment. | From time of dosing until 72 hours post-dose | The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of Ferriprox. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normal Hepatic Function (Healthy Volunteers) Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone | 8 |
| Mild Renal Impairment Mild renal impairment defined as eGFR 60-89 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone | 8 |
| Moderate Renal Impairment Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone | 8 |
| Severe Renal Impairment Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone | 8 |
| Total | 32 |
Baseline characteristics
| Characteristic | Normal Hepatic Function (Healthy Volunteers) | Mild Renal Impairment | Moderate Renal Impairment | Severe Renal Impairment | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 4 Participants | 2 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 6 Participants | 4 Participants | 6 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 32 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 6 Participants | 8 Participants | 8 Participants | 30 Participants |
| Region of Enrollment Canada | 8 participants | 8 participants | 8 participants | 8 participants | 32 participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 3 Participants | 2 Participants | 13 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 5 Participants | 6 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 8 | 5 / 8 | 1 / 8 | 1 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide
Ae24 (the amount excreted in urine from time zero to 24 hours) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Urine samples were collected at the intervals of -2 to 0 hours pre-dose and 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24 hours post-dose.
Time frame: 24 hour interval
Population: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Renal Function (Healthy Volunteers) | Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide | Ae24 for urine deferiprone | 78 mg | Standard Deviation 33 |
| Normal Renal Function (Healthy Volunteers) | Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide | e24 for urine deferiprone 3-O-Glucuronide | 5987 mg | Standard Deviation 1332 |
| Mild Renal Impairment | Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide | e24 for urine deferiprone 3-O-Glucuronide | 6608 mg | Standard Deviation 1630 |
| Mild Renal Impairment | Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide | Ae24 for urine deferiprone | 69 mg | Standard Deviation 20 |
| Moderate Renal Impairment | Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide | Ae24 for urine deferiprone | 36 mg | Standard Deviation 12 |
| Moderate Renal Impairment | Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide | e24 for urine deferiprone 3-O-Glucuronide | 5812 mg | Standard Deviation 929 |
| Severe Renal Impairment | Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide | Ae24 for urine deferiprone | 24 mg | Standard Deviation 10 |
| Severe Renal Impairment | Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide | e24 for urine deferiprone 3-O-Glucuronide | 5318 mg | Standard Deviation 1683 |
Primary
AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide
AUC0-∞ was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.
Time frame: 24 hour interval
Population: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Renal Function (Healthy Volunteers) | AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide | AUC0-∞ for serum deferiprone 3-O-Glucuronide | 78.1 μg*h/mL | Standard Deviation 27.8 |
| Normal Renal Function (Healthy Volunteers) | AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide | AUC0-∞ for serum deferiprone | 252.6 μg*h/mL | Standard Deviation 35.4 |
| Mild Renal Impairment | AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide | AUC0-∞ for serum deferiprone | 319.1 μg*h/mL | Standard Deviation 54.1 |
| Mild Renal Impairment | AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide | AUC0-∞ for serum deferiprone 3-O-Glucuronide | 76.9 μg*h/mL | Standard Deviation 15.7 |
| Moderate Renal Impairment | AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide | AUC0-∞ for serum deferiprone 3-O-Glucuronide | 74.9 μg*h/mL | Standard Deviation 15.1 |
| Moderate Renal Impairment | AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide | AUC0-∞ for serum deferiprone | 703.2 μg*h/mL | Standard Deviation 229.6 |
| Severe Renal Impairment | AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide | AUC0-∞ for serum deferiprone 3-O-Glucuronide | 70.9 μg*h/mL | Standard Deviation 8.5 |
| Severe Renal Impairment | AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide | AUC0-∞ for serum deferiprone | 1438.5 μg*h/mL | Standard Deviation 335.5 |
Primary
Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Cmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal, mild, moderate and severe renal impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.
Time frame: 24-hour interval
Population: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Renal Function (Healthy Volunteers) | Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Cmax for serum deferiprone | 37.1 μg/mL | Standard Deviation 12 |
| Normal Renal Function (Healthy Volunteers) | Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Cmax for serum deferiprone-3-o-glucuronide | 47.8 μg/mL | Standard Deviation 6.2 |
| Mild Renal Impairment | Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Cmax for serum deferiprone-3-o-glucuronide | 60.8 μg/mL | Standard Deviation 10.3 |
| Mild Renal Impairment | Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Cmax for serum deferiprone | 33.4 μg/mL | Standard Deviation 9.5 |
| Moderate Renal Impairment | Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Cmax for serum deferiprone | 43.3 μg/mL | Standard Deviation 22.9 |
| Moderate Renal Impairment | Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Cmax for serum deferiprone-3-o-glucuronide | 118.8 μg/mL | Standard Deviation 48.3 |
| Severe Renal Impairment | Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Cmax for serum deferiprone | 30.6 μg/mL | Standard Deviation 16.2 |
| Severe Renal Impairment | Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Cmax for serum deferiprone-3-o-glucuronide | 150.8 μg/mL | Standard Deviation 32.4 |
Primary
Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide
Fe24 (fraction of dose excreted in urine from time zero to 24 hours) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Urine samples were collected at the intervals of -2 to 0 hours pre-dose and 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24 hours post-dose. Some of the Fe24 values were over 100% which could be explained by variability in urine collection (e.g. incomplete collection of urine into the container) and volume measurement, as well as analytical imprecision.
Time frame: 24-hour interval
Population: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Renal Function (Healthy Volunteers) | Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide | Fe24 for urine deferiprone | 3.5 % of dose excreted in urine from 0-24 hr | Standard Deviation 1.6 |
| Normal Renal Function (Healthy Volunteers) | Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide | Fe24 for urine deferiprone 3-O-glucuronide | 115.0 % of dose excreted in urine from 0-24 hr | Standard Deviation 16.2 |
| Mild Renal Impairment | Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide | Fe24 for urine deferiprone 3-O-glucuronide | 123.2 % of dose excreted in urine from 0-24 hr | Standard Deviation 12.7 |
| Mild Renal Impairment | Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide | Fe24 for urine deferiprone | 2.9 % of dose excreted in urine from 0-24 hr | Standard Deviation 0.6 |
| Moderate Renal Impairment | Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide | Fe24 for urine deferiprone | 1.5 % of dose excreted in urine from 0-24 hr | Standard Deviation 0.5 |
| Moderate Renal Impairment | Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide | Fe24 for urine deferiprone 3-O-glucuronide | 104.5 % of dose excreted in urine from 0-24 hr | Standard Deviation 11.6 |
| Severe Renal Impairment | Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide | Fe24 for urine deferiprone | 1.0 % of dose excreted in urine from 0-24 hr | Standard Deviation 0.4 |
| Severe Renal Impairment | Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide | Fe24 for urine deferiprone 3-O-glucuronide | 97.9 % of dose excreted in urine from 0-24 hr | Standard Deviation 28.5 |
Primary
T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide
T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.
Time frame: 24 hour interval
Population: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Renal Function (Healthy Volunteers) | T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide | T1/2 for Serum Deferiprone | 1.68 hour | Standard Deviation 0.27 |
| Normal Renal Function (Healthy Volunteers) | T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide | T1/2 for Serum Deferiprone 3-O-Glucuronide | 2.14 hour | Standard Deviation 0.32 |
| Mild Renal Impairment | T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide | T1/2 for Serum Deferiprone 3-O-Glucuronide | 2.58 hour | Standard Deviation 0.45 |
| Mild Renal Impairment | T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide | T1/2 for Serum Deferiprone | 1.77 hour | Standard Deviation 0.17 |
| Moderate Renal Impairment | T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide | T1/2 for Serum Deferiprone | 2.03 hour | Standard Deviation 0.32 |
| Moderate Renal Impairment | T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide | T1/2 for Serum Deferiprone 3-O-Glucuronide | 2.58 hour | Standard Deviation 0.38 |
| Severe Renal Impairment | T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide | T1/2 for Serum Deferiprone | 2.20 hour | Standard Deviation 0.91 |
| Severe Renal Impairment | T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide | T1/2 for Serum Deferiprone 3-O-Glucuronide | 3.35 hour | Standard Deviation 0.48 |
Primary
Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Tmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose. The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation).
Time frame: 24 hour interval
Population: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Normal Renal Function (Healthy Volunteers) | Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Tmax for Serum Deferiprone | 0.50 hour |
| Normal Renal Function (Healthy Volunteers) | Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Tmax for Serum Deferiprone 3-O-glucuronide | 2.50 hour |
| Mild Renal Impairment | Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Tmax for Serum Deferiprone 3-O-glucuronide | 2.50 hour |
| Mild Renal Impairment | Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Tmax for Serum Deferiprone | 0.75 hour |
| Moderate Renal Impairment | Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Tmax for Serum Deferiprone | 1.00 hour |
| Moderate Renal Impairment | Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Tmax for Serum Deferiprone 3-O-glucuronide | 3.00 hour |
| Severe Renal Impairment | Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Tmax for Serum Deferiprone | 0.75 hour |
| Severe Renal Impairment | Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Tmax for Serum Deferiprone 3-O-glucuronide | 4.00 hour |
Secondary
Safety and Tolerability of Ferriprox® in Subjects With Renal Impairment.
The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of Ferriprox.
Time frame: From time of dosing until 72 hours post-dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Normal Renal Function (Healthy Volunteers) | Safety and Tolerability of Ferriprox® in Subjects With Renal Impairment. | 2 participants |
| Mild Renal Impairment | Safety and Tolerability of Ferriprox® in Subjects With Renal Impairment. | 5 participants |
| Moderate Renal Impairment | Safety and Tolerability of Ferriprox® in Subjects With Renal Impairment. | 1 participants |
| Severe Renal Impairment | Safety and Tolerability of Ferriprox® in Subjects With Renal Impairment. | 1 participants |