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

ApoPharma

Status and phase: Completed; Phase 4

Conditions: Renal Impairment

Treatments: Drug: Deferiprone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01770652

LA39-0412

Details and patient eligibility

About

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®.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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;

Trial design

32 participants in 4 patient groups

Normal renal function

Experimental group

Description:

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.

Treatment:

Drug: Deferiprone

Mild Renal Impairment

Experimental group

Description:

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.

Treatment:

Drug: Deferiprone

Moderate Renal Impairment

Experimental group

Description:

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.

Treatment:

Drug: Deferiprone

Severe Renal Impairment

Experimental group

Description:

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.

Treatment:

Drug: Deferiprone