Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency
An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency
Sponsor: OPKO Health, Inc.
Listed as NCT03588884, this PHASE4 trial focuses on CKD Stage 3 and CKD Stage 4 and remains completed. Sponsored by OPKO Health, Inc., it has been updated 12 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
12 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE4
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE4
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Jan 2023 — Jul 2024 [monthly]
Completed PHASE4
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Apr 2022 — Jan 2023 [monthly]
Completed PHASE4
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Jun 2021 — Apr 2022 [monthly]
Completed PHASE4
▶ Show 7 earlier versions
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Jan 2021 — Jun 2021 [monthly]
Completed PHASE4
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Aug 2020 — Jan 2021 [monthly]
Completed PHASE4
Status: Recruiting → Completed
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Oct 2019 — Aug 2020 [monthly]
Recruiting PHASE4
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Sep 2019 — Oct 2019 [monthly]
Recruiting PHASE4
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Jul 2019 — Sep 2019 [monthly]
Recruiting PHASE4
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Feb 2019 — Jul 2019 [monthly]
Recruiting PHASE4
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Aug 2018 — Feb 2019 [monthly]
Recruiting PHASE4
First recorded
Jun 2018
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- OPKO Health, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .