Secondary Hyperparathyroidism Due to Renal CausesPhase 2NCT03602261
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
A Phase 2 study testing Calcifediol Oral Capsule in people with Secondary Hyperparathyroidism Due to Renal Causes and Chronic Kidney Diseases, run by OPKO Health, Inc. at 18 sites in United States.
Trial summary
Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases, Vitamin D Deficiency
- What is being tested?
- Calcifediol Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 18 sitesUnited States
- Study dates
- 9 Jul 2018to 24 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- Scheduled kidney transplant or parathyroidectomy.
- History (prior 2 months) of corrected serum calcium ≥9.8 mg/dL or serum phosphorus
- ≥6.5 mg/dL if not receiving calcitriol or other 1α-hydroxylated vitamin D analog.
- Receipt of bisphosphonate therapy or other bone modifying treatment (eg, denosumab) within 6 months prior to enrollment.
- Known previous or concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease, intestinal malabsorption disorder, hepatitis or cardiovascular event that in the opinion of the investigator may worsen or reduce life expectancy, and/or interfere with participation in the study.
Show all 9Show fewer
- History of neurological/psychiatric disorder, including psychotic disorder or dementia, 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 the study drugs.
- Currently participating in, or has participated in, an interventional/investigational study within 30 days prior to study screening.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045
Research by Design, LLC
Chicago, Illinois, 60643
WCCT Global, Inc.
Cypress, California, 90630
Northshore University Health
Evanston, Illinois, 60201
Hacienda Dialysis Center
Hacienda Heights, California, 91745
Southwest Houston Research LTD
Houston, Texas, 77099
California Institute of Renal Research CKD/Dialysis & Transplant Division
La Mesa, California, 91942
Long Beach Quest Dialysis Center
Long Beach, California, 90807
Southwest MS Nephrology
McComb, Mississippi, 39601
Ontario Dialysis Center
Ontario, California, 91762
AKDHC Medical Research Services
Peoria, Arizona, 85381
AKDHC Medical Research Services
Phoenix, Arizona, 85027
AKDHC Medical Research Services
Phoenix, Arizona, 85035
AKDHC Medical Research Services
Phoenix, Arizona, 85258
Kidney & Hypertension Specialists
San Antonio, Texas, 78207
North America Research Institute, Inc.
San Dimas, California, 91773
Renal and Transplant Associates of New England
Springfield, Massachusetts, 01107
Laurel Canyon Dialysis, LLC
Sun Valley, California, 91352
About this study
Official title: 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.
Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI
Read the detailed description
A Multi-Center, Randomized, Two-Cohort Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of CTAP101 (calcifediol) Extended-Release Capsules to Treat Secondary Hyperparathyroidism (SHPT) in Subjects with Vitamin D Insufficiency (VDI) and Chronic Kidney Disease Requiring Regular Hemodialysis.
- Conditions
- Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases, Vitamin D Deficiency, Stage 5 Chronic Kidney Disease
- Being tested
- Calcifediol Oral Capsule, Placebo oral capsule
- Medical subject headings
- Renal Insufficiency, Chronic, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcifediol Oral CapsuleDrug
Also called CTAP101
Capsule, weekly
Placebo oral capsuleDrug
Capsule, weekly
| Study group | Role | What they receive |
|---|---|---|
| CTAP101 Capsules 900mcg/weekly | Active comparator | CTAP101 Oral Capsules/Calcifediol, calcidiol, 25-hydroxyvitamin D3, 900mcg/weekly for 26 weeks Receives: Drug: Calcifediol Oral Capsule |
| Placebo Capsules weekly | Placebo comparator | Placebo Oral Capsules/weekly for 26 weeks Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Response During Efficacy Assessment Period
To evaluate the efficacy of repeated dosing with 900 mcg per week of CTAP101 extended release (ER) Capsules versus placebo in raising mean serum total 25-hydroxyvitamin D (25D) to ≥50 ng/mL and in reducing mean plasma intact parathyroid hormone (iPTH) by at least 30% from pre-treatment baseline.
Measured: 26 weeks
Total 25-hydroxyvitamin D Response Analysis During Efficacy Period
Summary of participants with mean serum total 25-hydroxyvitamin D ≥50 ng/mL at the end of treatment
Measured: 26 weeks
Number of Participants With Intact Parathyroid Hormone (iPTH) Response During Efficacy Assessment Period
Summary of participants who experienced a reduction in mean plasma iPTH by greater than 30% from the pre-treatment baseline
Measured: 26 weeks
Pharmacokinetic (PK) Profile (Cmax) of Serum Calcifediol
To assess Cmax of serum calcifediol after a single dose of 900 mcg at the start of the study (Single Dose PK Period), and a repeat dose of 300 mcg at the end of the study (Repeat Dose PK Period)
Measured: 0, 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours post-dose (single and repeat dose)
Pharmacokinetic (PK) Profile (Tmax) of Serum Calcifediol
To assess Tmax of serum calcifediol after a single dose of 900 mcg at the start of the study (Single Dose PK Period), and a repeat dose of 300 mcg at the end of the study (Repeat Dose PK Period)
Measured: 0, 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours post-dose (single and repeat dose)
Pharmacokinetic (PK) Profile (AUC0-t) of Serum Calcifediol
To assess AUC0-t of serum calcifediol after a single dose of 900 mcg at the start of the study (Single Dose PK Period), and a repeat dose of 300 mcg at the end of the study (Repeat Dose PK Period)
Measured: 0, 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours post-dose (single and repeat dose)
Secondary outcomes (1)
Pharmacodynamic Analysis of 1,25-dihydroxyvitamin D
Effect of CTAP101 on 1,25-dihydroxyvitamin D
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start9 Jul 2018
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Why it stopped: Cohort 1 completed and cohort 2 terminated prior to initiation per company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Secondary Hyperparathyroidism Due to Renal CausesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602261
- Sponsor's protocol ID
- CTAP101-CL-2010
- Status last verified
- Apr 2026
- First submitted
- 13 Jul 2018
- Last updated
- 3 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03602261
- Acronym / sponsor ID
- CTAP101-CL-2010
- Conditions
- Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases, Vitamin D Deficiency, Stage 5 Chronic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Cohort 1 completed and cohort 2 terminated prior to initiation per company decision
- Enrolment
- 44 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 30 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI
Detailed description
A Multi-Center, Randomized, Two-Cohort Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of CTAP101 (calcifediol) Extended-Release Capsules to Treat Secondary Hyperparathyroidism (SHPT) in Subjects with Vitamin D Insufficiency (VDI) and Chronic Kidney Disease Requiring Regular Hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTAP101 Capsules 900mcg/weekly | Active comparator | Drug: Calcifediol Oral CapsuleCTAP101 Oral Capsules/Calcifediol, calcidiol, 25-hydroxyvitamin D3, 900mcg/weekly for 26 weeks |
| Placebo Capsules weekly | Placebo comparator | Drug: Placebo oral capsulePlacebo Oral Capsules/weekly for 26 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Scheduled kidney transplant or parathyroidectomy.
- History (prior 2 months) of corrected serum calcium ≥9.8 mg/dL or serum phosphorus
- ≥6.5 mg/dL if not receiving calcitriol or other 1α-hydroxylated vitamin D analog.
- Receipt of bisphosphonate therapy or other bone modifying treatment (eg, denosumab) within 6 months prior to enrollment.
- Known previous or concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease, intestinal malabsorption disorder, hepatitis or cardiovascular event that in the opinion of the investigator may worsen or reduce life expectancy, and/or interfere with participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcifediol Oral CapsuleAlso: CTAP101Capsule, weekly | Drug | CTAP101 Capsules 900mcg/weekly |
| Placebo oral capsuleCapsule, weekly | Drug | Placebo Capsules weekly |
Primary outcome
Number of Participants With Response During Efficacy Assessment Period
Time frame: 26 weeks
To evaluate the efficacy of repeated dosing with 900 mcg per week of CTAP101 extended release (ER) Capsules versus placebo in raising mean serum total 25-hydroxyvitamin D (25D) to ≥50 ng/mL and in reducing mean plasma intact parathyroid hormone (iPTH) by at least 30% from pre-treatment baseline.
Total 25-hydroxyvitamin D Response Analysis During Efficacy Period
Time frame: 26 weeks
Summary of participants with mean serum total 25-hydroxyvitamin D ≥50 ng/mL at the end of treatment
Number of Participants With Intact Parathyroid Hormone (iPTH) Response During Efficacy Assessment Period
Time frame: 26 weeks
Summary of participants who experienced a reduction in mean plasma iPTH by greater than 30% from the pre-treatment baseline
Pharmacokinetic (PK) Profile (Cmax) of Serum Calcifediol
Time frame: 0, 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours post-dose (single and repeat dose)
To assess Cmax of serum calcifediol after a single dose of 900 mcg at the start of the study (Single Dose PK Period), and a repeat dose of 300 mcg at the end of the study (Repeat Dose PK Period)
Pharmacokinetic (PK) Profile (Tmax) of Serum Calcifediol
Time frame: 0, 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours post-dose (single and repeat dose)
To assess Tmax of serum calcifediol after a single dose of 900 mcg at the start of the study (Single Dose PK Period), and a repeat dose of 300 mcg at the end of the study (Repeat Dose PK Period)
Pharmacokinetic (PK) Profile (AUC0-t) of Serum Calcifediol
Time frame: 0, 4, 8, 12, 16, 20, 24, 30, 36, 42 and 48 hours post-dose (single and repeat dose)
To assess AUC0-t of serum calcifediol after a single dose of 900 mcg at the start of the study (Single Dose PK Period), and a repeat dose of 300 mcg at the end of the study (Repeat Dose PK Period)
1 secondary outcome
Pharmacodynamic Analysis of 1,25-dihydroxyvitamin D
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Secondary Hyperparathyroidism Due to Renal Causes
Not yet recruitingObservational study
Retrospective Analysis of Quality of Life Changes in Patients Undergoing Parathyroidectomy for End-Stage Renal Disease
Secondary Hyperparathyroidism Due to Renal Causes, End Stage Renal Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcifediol Oral Capsule in people with Secondary Hyperparathyroidism Due to Renal Causes and Chronic Kidney Diseases, run by OPKO Health, Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Response During Efficacy Assessment Period (time frame: 26 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.