Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-releas… (NCT07494045) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants
United States40 participantsStarted 2026-06
Plain-language summary
The goal of this clinical trial is to evaluate safety, tolerability, and how CTAP101 Capsules work to treat Pediatric Participants with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency. The main questions it aims to answer are:
1. To assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of CTAP101 Capsules
2. To investigate the safety and tolerability of CTAP101 Capsules
Participants will take a daily dosage of CTAP101 Capsules at bedtime for 8 weeks.
Who can participate
Age range1 Month – 17 Years
SexALL
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Inclusion criteria
✓. Be 8 to \<18 years of age with a body weight of ≥40 kg.
✓. Be diagnosed with stage 3 or 4 CKD at least six months prior to the screening visit (Visit 1) 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.
✓. Exhibit during the initial or, if necessary, a screening visit after washout:
✓. Plasma iPTH \>85 pg/mL;
✓. Serum Ca \<9.8 mg/dL;
✓. Serum P ≤5.5 mg/dL; and
✓. Serum 25D \<30 ng/mL.
Exclusion criteria
✕. Kidney transplant within the 26 weeks preceding screening or kidney transplant rejection within the 26 weeks preceding screening.
✕
What they're measuring
1
Apparent clearance (CL/F)
Timeframe: Up to 14 weeks
2
Volume of distribution (Vd/F)
Timeframe: Up to 14 weeks
3
Terminal elimination half-life (t1/2)
Timeframe: Up to 14 weeks
4
Incidence of treatment emergent adverse events (TEAE)
. No history of parathyroidectomy or planned parathyroidectomy.
✕. History (prior three months) of serum Ca ≥9.8 mg/dL.
✕. Use of calcimimetic or calcifediol therapy within three months prior to consent.
✕. Use of bisphosphonate or denosumab therapy within six months prior to consent.
✕. Known or suspected hypersensitivity to any of the constituents in CTAP101 Capsules.
✕. 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 abnormal ECG 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 FU schedule unlikely.