An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or No Renal Impairment

NCT ID: NCT01770652

Last Updated: 2014-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-08-31

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.

Conditions

Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Normal renal function

Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m\^2. All subjects received a single 33 mg/kg oral dose of deferiprone.

Group Type: EXPERIMENTAL

Deferiprone

Intervention Type: DRUG

Oral iron chelator

Mild Renal Impairment

Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m\^2. All subjects received a single 33 mg/kg oral dose of deferiprone.

Group Type: EXPERIMENTAL

Deferiprone

Intervention Type: DRUG

Oral iron chelator

Moderate Renal Impairment

Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m\^2. All subjects received a single 33 mg/kg oral dose of deferiprone.

Group Type: EXPERIMENTAL

Deferiprone

Intervention Type: DRUG

Oral iron chelator

Severe Renal Impairment

Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m\^2. All subjects received a single 33 mg/kg oral dose of deferiprone.

Group Type: EXPERIMENTAL

Deferiprone

Intervention Type: DRUG

Oral iron chelator

Interventions

Deferiprone

Oral iron chelator

Intervention Type: DRUG

Other Intervention Names

Ferriprox; L1; DFP

Eligibility Criteria

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).

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ApoPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Tricta, MD

Role: STUDY_CHAIR

ApoPharma

Locations

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Algorithme Pharma Inc.

Mount Royal, Quebec, Canada

Countries

Canada

Other Identifiers

LA39-0412

Identifier Type: -

Identifier Source: org_study_id