Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary… (NCT05543928) | Clinical Trial Compass
TerminatedPhase 3
Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism
Stopped: FDA changed the post-marketing requirement necessitating a new study design and protocol.
United States2 participantsStarted 2023-01-31
Plain-language summary
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study in children with stage 3-4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT) and vitamin D insufficiency.
Who can participate
Age range
8 Years – 17 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
. Cohort 1: Be 12 to \<18 years of age and have a body weight of ≥40 kg; Cohort 2: be 8 to \<12 years of age and have a body weight of ≥20 kg.
. Be diagnosed with stage 3 to 4 CKD at least six months prior to the screening visit, and have an eGFR of ≥15 to \<60 mL/min/1.73m2 at screening.
. Be without any disease state or physical condition that might impair evaluation of safety or which, in the investigator's opinion, would interfere with study participation, including:
. Serum albumin ≤ 3.0 g/dL;
. Serum transaminase (ALT or SGPT, AST or SGOT) \> 2.5 times the upper limit of normal at screening; and,
. Urinary albumin excretion of \>3000 mcg/mg creatinine.
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
Numbers of Subjects Who Attained Mean Decrease in Plasma iPTH of 30% From Baseline
. History of or planned kidney transplant or parathyroidectomy.
. History (prior three months) of serum calcium ≥9.8 mg/dL.
. Use of bisphosphonate therapy (denosumab) within six months prior to enrollment.
. Known previous or concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease or cardiovascular event or hepatitis, or physical condition that in the opinion of the investigator may worsen and/or interfere with participation in the study.
. History of neurological/psychiatric disorder, including psychotic disorder, or any reason which, in the opinion of the investigator makes adherence to a treatment or follow up schedule unlikely.
. Known or suspected hypersensitivity to any of the constituents of either investigational product.
. Currently participating in, or has participated in, an interventional/investigational study within 30 days prior to study screening.