Trial · NCT01704079
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
NCT01704079, Phase 3, Completed, OPKO IP Holdings II, Inc.; results first posted 2016-08-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency. Trials, record NCT01704079. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01704079
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
- NCT number
- NCT01704079
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 216 participants, actual
- Lead sponsor
- OPKO IP Holdings II, Inc.
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Interventions
- CTAP101 30 μg capsules, Sugar pill to CTAP101 30 μg capsules
- First posted
- 2012-10-11
- Last updated
- 2025-01-13
- Results first posted
- 2016-08-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline | Approximately 6 months | 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 |
| Secondary | Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline | Approximately 6 months | 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 |
| Secondary | Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D | Approximately 6 months | Subjects in the intent to treat population with normal serum total 25-hydroxyvitamin D (\>/= 30 ng/dL) |
| Secondary | Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D | Approximately 6 months | Subjects in the per protocol population with normal serum total 25-hydroxyvitamin D (\>/= 30 ng/mL) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline | Approximately 6 months | Intent to treat | participants | NUMBER |
| SECONDARY | Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline | Approximately 6 months | Per protocol | participants | NUMBER |
| SECONDARY | Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D | Approximately 6 months | Intent to treat | participants | NUMBER |
| SECONDARY | Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D | Approximately 6 months | Per protocol | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline | Sugar Pill to CTAP101 30 μg | 5 | participants | ||
| Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline | CTAP101 30 μg Capsules | 49 | participants | ||
| Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline | Sugar Pill to CTAP101 30 μg | 5 | participants | ||
| Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline | CTAP101 30 μg Capsules | 47 | participants | ||
| Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D | Sugar Pill to CTAP101 30 μg | 5 | participants | ||
| Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D | CTAP101 30 μg Capsules | 120 | participants | ||
| Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D | Sugar Pill to CTAP101 30 μg | 5 | participants | ||
| Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D | CTAP101 30 μg Capsules | 116 | participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sugar Pill to CTAP101 30 μg | 72 | |
| Overall Study | STARTED | CTAP101 30 μg Capsules | 144 | |
| Overall Study | Entered Extension Study | Sugar Pill to CTAP101 30 μg | 53 | |
| Overall Study | Entered Extension Study | CTAP101 30 μg Capsules | 102 | |
| Overall Study | COMPLETED | Sugar Pill to CTAP101 30 μg | 58 | |
| Overall Study | COMPLETED | CTAP101 30 μg Capsules | 121 | |
| Overall Study | NOT COMPLETED | Sugar Pill to CTAP101 30 μg | 14 | |
| Overall Study | NOT COMPLETED | CTAP101 30 μg Capsules | 23 |
Source ClinicalTrials.gov
Adverse events96
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Sugar Pill to CTAP101 30 μg | 4 | 72 | 4 |
| other | Constipation | Gastrointestinal disorders | CTAP101 30 μg Capsules | 5 | 144 | 5 |
| other | Oedema peripheral | General disorders | Sugar Pill to CTAP101 30 μg | 3 | 72 | 3 |
| other | Oedema peripheral | General disorders | CTAP101 30 μg Capsules | 9 | 144 | 9 |
| other | Nasopharyngitis | Infections and infestations | Sugar Pill to CTAP101 30 μg | 1 | 72 | 1 |
| other | Nasopharyngitis | Infections and infestations | CTAP101 30 μg Capsules | 8 | 144 | 8 |
| other | Gout | Metabolism and nutrition disorders | Sugar Pill to CTAP101 30 μg | 5 | 72 | 5 |
| other | Gout | Metabolism and nutrition disorders | CTAP101 30 μg Capsules | 6 | 144 | 6 |
| other | Metabolic acidosis | Metabolism and nutrition disorders | Sugar Pill to CTAP101 30 μg | 4 | 72 | 4 |
| other | Metabolic acidosis | Metabolism and nutrition disorders | CTAP101 30 μg Capsules | 1 | 144 | 1 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sugar Pill to CTAP101 30 μg | ||
| Total, all-cause mortality | CTAP101 30 μg Capsules | ||
| Total, other adverse events | Sugar Pill to CTAP101 30 μg | 18 | 72 |
| Total, other adverse events | CTAP101 30 μg Capsules | 32 | 144 |
| Total, serious adverse events | Sugar Pill to CTAP101 30 μg | 11 | 72 |
| Total, serious adverse events | CTAP101 30 μg Capsules | 22 | 144 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sugar Pill to CTAP101 30 μg vs CTAP101 30 μg Capsules: Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D | Trial comparisons |
Sugar Pill to CTAP101 30 μg vs 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 | Trial comparisons |
| Sugar Pill to CTAP101 30 μg vs CTAP101 30 μg Capsules: Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D | Trial comparisons |
Sugar Pill to CTAP101 30 μg vs 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 | Trial comparisons |
| Sugar Pill to CTAP101 30 μg vs CTAP101 30 μg Capsules: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01704079
GET https://conductscience.org/api/trials/v1/NCT01704079/events?page=2