deltatrials
Terminated PHASE2 INTERVENTIONAL 2-arm NCT03602261

Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI

A Multi-Center, Randomized, Two-Cohort Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of CTAP101 (Calcifediol) Extended-Release Capsules to Treat Secondary Hyperparathyroidism in Subjects With Vitamin D Insufficiency and Chronic Kidney Disease Requiring Regular Hemodialysis.

Sponsor: OPKO Health, Inc.

Conditions Chronic Kidney Diseases Secondary Hyperparathyroidism Due to Renal Causes Stage 5 Chronic Kidney Disease Vitamin D Deficiency
Interventions Calcifediol Oral Capsule Placebo oral capsule
Updated 12 times since 2018 Last updated: Mar 12, 2025 Started: Jul 9, 2018 Primary completion: Feb 24, 2021 Completion: Feb 24, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Cohort 1 completed and cohort 2 terminated prior to initiation per company decision

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Listed as NCT03602261, this PHASE2 trial focuses on Chronic Kidney Diseases and Secondary Hyperparathyroidism Due to Renal Causes and remains terminated or withdrawn. 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

~Aug 2018 – ~Feb 2019 · 6 months · monthly snapshotRecruiting~Feb 2019 – ~Jul 2019 · 5 months · monthly snapshotRecruiting~Jul 2019 – ~Sep 2019 · 2 months · monthly snapshotRecruiting~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshotRecruiting~Oct 2019 – ~Jan 2021 · 15 months · monthly snapshotRecruiting~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshotRecruiting~Apr 2021 – ~Jun 2022 · 14 months · monthly snapshotActive Not Recruiting~Jun 2022 – ~Jun 2024 · 24 months · monthly snapshotActive Not Recruiting~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshotUnknown~Apr 2025 – present · 14 months · monthly snapshotTerminated

Change History

12 versions recorded

  1. Apr 2025 — Present [monthly]

    Terminated PHASE2

    Status: Unknown → Terminated

  2. Sep 2024 — Apr 2025 [monthly]

    Unknown PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE2

    Status: Unknown Status → Unknown

  4. Jun 2024 — Jul 2024 [monthly]

    Unknown Status PHASE2

    Status: Active Not Recruiting → Unknown Status

  5. Jun 2022 — Jun 2024 [monthly]

    Active Not Recruiting PHASE2

▶ Show 7 earlier versions

  1. Apr 2021 — Jun 2022 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  2. Jan 2021 — Apr 2021 [monthly]

    Recruiting PHASE2

  3. Oct 2019 — Jan 2021 [monthly]

    Recruiting PHASE2

  4. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE2

  5. Jul 2019 — Sep 2019 [monthly]

    Recruiting PHASE2

  6. Feb 2019 — Jul 2019 [monthly]

    Recruiting PHASE2

  7. Aug 2018 — Feb 2019 [monthly]

    Recruiting PHASE2

    First recorded

Jul 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • OPKO Health, Inc.
Data source: OPKO Health, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aurora, United States , Chicago, United States , Cypress, United States , Evanston, United States , Hacienda Heights, United States , Houston, United States , La Mesa, United States , Long Beach, United States , McComb, United States , Ontario, United States and 6 more locations