An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or N… (NCT01770652) | Clinical Trial Compass
CompletedPhase 4
An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or No Renal Impairment
Canada32 participantsStarted 2013-01
Plain-language 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®.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult males or females, 18 - 75 years of age (inclusive);
. Body weight ≥ 45 kg;
. Body mass index (BMI) range of approximately 18.5-32 kg/m\^2 (inclusive);
. Absolute neutrophil count (ANC) of \>1.5x10\^9/L;
. Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, vital signs, physical examination);
. eGFR ≥ 90 mL/min/1.73m\^2;
. Considered clinically stable in the opinion of the Investigator;
. 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
. History of renal transplant;
. Subjects undergoing any method of dialysis;
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Timeframe: 24-hour interval
2
Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Timeframe: 24 hour interval
3
AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide
Timeframe: 24 hour interval
4
T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide
Timeframe: 24 hour interval
5
Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide
Timeframe: 24 hour interval
6
Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide
. 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.);
. Clinically significant abnormalities on 12-lead ECG (e.g., QTcF≥430 ms in males or ≥450 ms in females);
. Evidence of liver damage: hepatitis B and C; aspartate aminotransferase (AST), alanine aminotransferase (ALT) that is considered clinically significant by the Investigator;
. Participation in another clinical trial within 28 days prior to the study drug administration;