A Phase 3 interventional study of CTAP101 30 μg capsules and Sugar pill to CTAP101 30 μg capsules in Chronic Kidney Disease, Hyperparathyroidism, Secondary and Vitamin D Deficiency, sponsored by OPKO IP Holdings II, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by OPKO IP Holdings II, Inc. (part of OPKO Health, Inc.) · Phase 3, Interventional, and Treatment
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
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.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 216 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →OPKO IP Holdings II, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
First submitted before OPKO IP Holdings II, Inc. became part of OPKO Health, Inc..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: CTAP101 30 μg capsules · Other: Sugar pill to CTAP101 30 μg capsules
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.
Other: Sugar pill to CTAP101 30 μg capsules
CTAP101 30 μg capsule taken daily at bedtime
Also known as: Calcifediol
Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
Also known as: Placebo
Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline
Number of subjects in the intent to treat population attaining mean decrease in plasma intact Parathyroid Hormone (iPTH) of ≥30% from P\\pre-treatment baseline in the efficacy assessment phase (EAP) referred to as responders
Time frame: Approximately 6 months
Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline
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
Time frame: 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)
Time frame: 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)
Time frame: Approximately 6 months
This multicenter study was conducted at 45 investigational sites within the US. Subjects were enrolled and treated from 04 February 2013 through 13 August 2014.
| Milestone | Sugar Pill to CTAP101 30 μg | CTAP101 30 μg Capsules |
|---|---|---|
| Started | 72 | 144 |
| Entered extension study | 53 | 102 |
| Completed | 58 | 121 |
| Not completed | 14 | 23 |
| Withdrew: Withdrawal by subject | 5 | 7 |
| Withdrew: Lost to follow-up | 2 | 5 |
| Withdrew: Adverse event | 4 | 7 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Subject noncompliance | 2 | 3 |
| Withdrew: Serum calcium >/= 11.0 mg/dl, repeat con | 0 | 1 |
Number of subjects in the intent to treat population attaining mean decrease in plasma intact Parathyroid Hormone (iPTH) of ≥30% from P\\pre-treatment baseline in the efficacy assessment phase (EAP) referred to as responders
| participants | Sugar Pill to CTAP101 30 μg | CTAP101 30 μg Capsules |
|---|---|---|
| Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline | 5 | 49 |
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
| participants | Sugar Pill to CTAP101 30 μg | CTAP101 30 μg Capsules |
|---|---|---|
| Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline | 5 | 47 |
Subjects in the intent to treat population with normal serum total 25-hydroxyvitamin D (\>/= 30 ng/dL)
| participants | Sugar Pill to CTAP101 30 μg | CTAP101 30 μg Capsules |
|---|---|---|
| Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D | 5 | 120 |
Subjects in the per protocol population with normal serum total 25-hydroxyvitamin D (\>/= 30 ng/mL)
| participants | Sugar Pill to CTAP101 30 μg | CTAP101 30 μg Capsules |
|---|---|---|
| Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D | 5 | 116 |
Collected over 6 months from randomization to end of therapy. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sugar Pill to CTAP101 30 μg | — | 11/72 (15.3%) | 18/72 (25%) |
| CTAP101 30 μg Capsules | — | 22/144 (15.3%) | 32/144 (22.2%) |
| Event | Sugar Pill to CTAP101 30 μg | CTAP101 30 μg Capsules |
|---|---|---|
| SepsisInfections and infestations | 2/72 | 0/144 |
| DehydrationMetabolism and nutrition disorders | 2/72 | 1/144 |
| Cardiac failure congestiveCardiac disorders | 0/72 | 3/144 |
| PneumoniaInfections and infestations | 1/72 | 3/144 |
| Blood creatinine increasedInvestigations | 0/72 | 3/144 |
| AnaemiaBlood and lymphatic system disorders | 0/72 | 2/144 |
| Acute myocardial infarctionCardiac disorders | 1/72 | 1/144 |
| Cardiac failureCardiac disorders | 1/72 | 1/144 |
| AstheniaGeneral disorders | 1/72 | 0/144 |
| Chest painGeneral disorders | 1/72 | 1/144 |
| Event | Sugar Pill to CTAP101 30 μg | CTAP101 30 μg Capsules |
|---|---|---|
| HypertensionVascular disorders | 6/72 | 8/144 |
| GoutMetabolism and nutrition disorders | 5/72 | 6/144 |
| Oedema peripheralGeneral disorders | 3/72 | 9/144 |
| ConstipationGastrointestinal disorders | 4/72 | 5/144 |
| NasopharyngitisInfections and infestations | 1/72 | 8/144 |
| Metabolic acidosisMetabolism and nutrition disorders | 4/72 | 1/144 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 4/72 | 3/144 |
| Age, Continuous(years) | Sugar Pill to CTAP101 30 μg | CTAP101 30 μg Capsules | Total |
|---|---|---|---|
| Mean | 65.3 ± 10.06 | 66.8 ± 10.90 | 66.3 ± 10.63 |
| Sex: Female, Male(Participants) | Sugar Pill to CTAP101 30 μg | CTAP101 30 μg Capsules | Total |
|---|---|---|---|
| Female | 39 | 71 | 110 |
| Male | 33 | 73 | 106 |
| Region of Enrollment(participants) | Sugar Pill to CTAP101 30 μg | CTAP101 30 μg Capsules | Total |
|---|---|---|---|
| United States | 72 | 144 | 216 |
The record gives a start of Nov 2012, a primary completion of Aug 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2016, 2 years after primary completion. A results delay was requested in Oct 2015.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Modified-release Calcifediol Capsule
Renal Insufficiency, Chronic →