Chronic Kidney DiseasePhase 3NCT01651000
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
A Phase 3 study testing CTAP101 30 μg capsules and Sugar pill to CTAP101 30 μg capsules in people with Chronic Kidney Disease and Hyperparathyroidism, Secondary, run by OPKO IP Holdings II, Inc. at 1 site in United States.
Trial summary
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- What is being tested?
- CTAP101 30 μg capsules and Sugar pill to CTAP101 30 μg capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jul 2014
- Phase
- Phase 3
- 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
- Urinary albumin excretion ≤ 3000 mcg/mg of creatinine
- Stage 3 or 4 CKD
- Plasma iPTH: ≥ 85 pg/mL and < 500 pg/mL
- Serum Ca: ≥ 8.4 mg/dL and < 9.8 mg/dL
- Serum P: ≥ 2.0 mg/dL and < 5.0 mg/dL
- Serum 25-hydroxyvitamin D: ≥ 10 ng/mL and < 30 ng/mL.
- Stable dose of Vitamin D therapy ≤ 1600 IU/day and receiving same dose for at least 2 months
Who cannot join
- History of kidney transplant or parathyroidectomy
- Spot urine calcium:creatinine ratio > 0.2 (>200 mg/g Cr)
- Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis
- Currently on dialysis
- Use of pharmacological dose of ergocalciferol or cholecalciferol (≥ 50,000 IU mcg per month) during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of CTAP101 Capsules to Treat Secondary Hyperparathyroidism in Subjects With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated
Read the detailed description
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CTAP101 Capsules administered for 26 weeks to treat SHPT in subjects ≥18 years of age with stage 3 or 4 CKD and vitamin D insufficiency. The study will be conducted at approximately 40 sites within the United States (US). Approximately 550 subjects will be screened to randomize approximately 210 eligible subjects, stratified by CKD stage (approximately 105 subjects in each stage) in a 2:1 ratio to receive either CTAP101 Capsules or matching placebo. An Interactive Voice Response System (IVRS) will provide study treatment group assignments using the computer-generated randomization code provided by the IVRS vendor. Subjects will receive an initial daily dose of 1 capsule (CTAP101 Capsules, 30 µg, or matching placebo) for the first 12 weeks. After l2 weeks (visit 8) and per pre-defined criteria, the dose may be increased in a blinded fashion by the IVRS with oversight by an independent medical monitor.
- Being tested
- CTAP101 30 μg capsules, Sugar pill to CTAP101 30 μg capsules
- Keywords
- Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Kidney Diseases, Kidney Failure, Renal Insufficiency, Chronic
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary, Vitamin D Deficiency, Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTAP101 30 μg capsulesDrug
Also called Calcifediol
CTAP101 30 μg capsule taken daily at bedtime.
Sugar pill to CTAP101 30 μg capsulesOther
Also called Placebo
Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
| Study group | Role | What they receive |
|---|---|---|
| CTAP101 30 μg capsules | Active comparator | 1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26. Receives: Drug: CTAP101 30 μg capsules; Other: Sugar pill to CTAP101 30 μg capsules |
| Sugar pill to CTAP101 30 μg capsule | Placebo comparator | 1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26. Receives: Other: Sugar pill to CTAP101 30 μg capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values
Number of subjects in the intent to treat population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.
Measured: Approximately 6 months
Secondary outcomes (3)
Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values
Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.
Measured: Approximately 6 months
Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D
Subjects in the Intent to Treat Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/dL)
Measured: Approximately 6 months
Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D
Subjects in the Per Protocol Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/mL)
Measured: Approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2014
- Study completionJul 2014
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 Chronic Kidney DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO IP Holdings II, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Melnick, MD, Study director, Opko Renal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651000
- Sponsor's protocol ID
- CTAP101-CL-3001
- Status last verified
- Dec 2019
- First submitted
- 23 Jul 2012
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of CTAP101 Capsules to Treat Secondary Hyperparathyroidism in Subjects With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency
- ClinicalTrials.gov ID
- NCT01651000
- Acronym / sponsor ID
- CTAP101-CL-3001
- Keywords
- Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Kidney Diseases, Kidney Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- OPKO IP Holdings II, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Posted 17 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated
Detailed description
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CTAP101 Capsules administered for 26 weeks to treat SHPT in subjects ≥18 years of age with stage 3 or 4 CKD and vitamin D insufficiency. The study will be conducted at approximately 40 sites within the United States (US). Approximately 550 subjects will be screened to randomize approximately 210 eligible subjects, stratified by CKD stage (approximately 105 subjects in each stage) in a 2:1 ratio to receive either CTAP101 Capsules or matching placebo. An Interactive Voice Response System (IVRS) will provide study treatment group assignments using the computer-generated randomization code provided by the IVRS vendor. Subjects will receive an initial daily dose of 1 capsule (CTAP101 Capsules, 30 µg, or matching placebo) for the first 12 weeks. After l2 weeks (visit 8) and per pre-defined criteria, the dose may be increased in a blinded fashion by the IVRS with oversight by an independent medical monitor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTAP101 30 μg capsules | Active comparator | Drug: CTAP101 30 μg capsules, Other: Sugar pill to CTAP101 30 μg capsules1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26. |
| Sugar pill to CTAP101 30 μg capsule | Placebo comparator | Other: Sugar pill to CTAP101 30 μg capsules1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Urinary albumin excretion ≤ 3000 mcg/mg of creatinine
- Stage 3 or 4 CKD
- Plasma iPTH: ≥ 85 pg/mL and < 500 pg/mL
- Serum Ca: ≥ 8.4 mg/dL and < 9.8 mg/dL
- Serum P: ≥ 2.0 mg/dL and < 5.0 mg/dL
Key exclusion criteria (5 listed)
- History of kidney transplant or parathyroidectomy
- Spot urine calcium:creatinine ratio > 0.2 (>200 mg/g Cr)
- Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis
- Currently on dialysis
- Use of pharmacological dose of ergocalciferol or cholecalciferol (≥ 50,000 IU mcg per month) during 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 |
|---|---|---|
| CTAP101 30 μg capsulesAlso: CalcifediolCTAP101 30 μg capsule taken daily at bedtime. | Drug | CTAP101 30 μg capsules |
| Sugar pill to CTAP101 30 μg capsulesAlso: PlaceboSugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime. | Other | CTAP101 30 μg capsules, Sugar pill to CTAP101 30 μg capsule |
Primary outcome
Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values
Time frame: Approximately 6 months
Number of subjects in the intent to treat population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.
3 secondary outcomes
Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values
Time frame: Approximately 6 months
Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D
Time frame: Approximately 6 months
Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D
Time frame: Approximately 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joel Melnick, MD study director
Opko Renal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CTAP101 30 μg capsules and Sugar pill to CTAP101 30 μg capsules in people with Chronic Kidney Disease and Hyperparathyroidism, Secondary, run by OPKO IP Holdings II, Inc. at 1 site 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 17 Aug 2016). 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 in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values (time frame: Approximately 6 months). 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 13 Jan 2025.