Clinical trial NCT01770652: An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or No Renal Impairment
Official title: An Open-label Study to Compare the Pharmacokinetic Profiles of a Single Dose of Ferriprox in Subjects With Impaired Renal Function and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Impairment
Keywords: Renal Impairment
Kidney Impairment
Kidney Disease
Ferriprox
Deferiprone
DFP (deferiprone)
L1
Lead sponsor: ApoPharma
Sponsor class: INDUSTRY
First posted: 2013-01-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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;

Primary outcomes:
measure: Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
timeFrame: 24-hour interval
measure: Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
timeFrame: 24 hour interval
measure: AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide
timeFrame: 24 hour interval
measure: T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide
timeFrame: 24 hour interval
measure: Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide
timeFrame: 24 hour interval
measure: Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide
timeFrame: 24-hour interval
Secondary outcomes:
measure: Safety and Tolerability of Ferriprox® in Subjects With Renal Impairment.
timeFrame: From time of dosing until 72 hours post-dose
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Mount-Royal
country: Canada
facility: Algorithme Pharma Inc.
state: Quebec
Study officials:
affiliation: ApoPharma
name: Fernando Tricta, MD
role: STUDY_CHAIR
References: