Trial · NCT02282813
Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002
NCT02282813, Phase 3, Completed, OPKO Health, Inc.; results first posted 2016-08-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002. Trials, record NCT02282813. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02282813
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002
- NCT number
- NCT02282813
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 298 participants, actual
- Lead sponsor
- OPKO Health, Inc.
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Interventions
- CTAP101 Capsules, Calcitriol, Doxercalciferol, Paricalcitol
- First posted
- 2014-11-04
- Last updated
- 2016-09-29
- 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 a Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT) | up to 6 months | Number of subjects in the intent to treat population with a mean reduction in plasma intact parathyroid hormone (iPTH) of \>/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders |
| Secondary | Number of Participants in the Per Protocol Population With Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT) | up to 6 months | Number of subjects in the per protocol population with a mean reduction in plasma intact parathyroid hormone (iPTH) of \>/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders |
| Secondary | Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT) | up to 6 months | Number of Participants in the Intent to Treat Population with serum 25-hydroxyvitamin D \>/= 30 ng/mL at End of Treatment (EOT) |
| Secondary | Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT) | up to 6 months | Number of Participants in the per protocol population with serum 25-hydroxyvitamin D \>/= 30 ng/mL at End of Treatment (EOT) |
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 a Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT) | up to 6 months | Intent to treat | participants | NUMBER |
| SECONDARY | Number of Participants in the Per Protocol Population With Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT) | up to 6 months | Per protocol | participants | NUMBER |
| SECONDARY | Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT) | up to 6 months | Intent to treat | participants | NUMBER |
| SECONDARY | Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT) | up to 6 months | Per protocol | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
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 a Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT) | CTAP101 Capsules (Not Randomized; 6 Mos Treatment) | 34 | participants | ||
| Number of Participants in the Intent to Treat Population With a Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT) | CTAP101 Capsules (Not Randomized; 12 Mos Treatment) | 66 | participants | ||
| Number of Participants in the Intent to Treat Population With a Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT) | CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive | 30 | participants | ||
| Number of Participants in the Per Protocol Population With Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT) | CTAP101 Capsules (Not Randomized; 6 Mos Treatment) | 34 | participants | ||
| Number of Participants in the Per Protocol Population With Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT) | CTAP101 Capsules (Not Randomized; 12 Mos Treatment) | 64 | participants | ||
| Number of Participants in the Per Protocol Population With Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT) | CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive | 29 | participants | ||
| Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT) | CTAP101 Capsules (Not Randomized; 6 Mos Treatment) | 87 | participants | ||
| Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT) | CTAP101 Capsules (Not Randomized; 12 Mos Treatment) | 124 | participants | ||
| Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT) | CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive | 38 | participants | ||
| Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT) | CTAP101 Capsules (Not Randomized; 6 Mos Treatment) | 86 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CTAP101 Capsules (Not Randomized; 6 Mos Treatment) | 103 | |
| Overall Study | STARTED | CTAP101 Capsules (Not Randomized; 12 Mos Treatment) | 153 | |
| Overall Study | STARTED | CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive | 42 | |
| Overall Study | COMPLETED | CTAP101 Capsules (Not Randomized; 6 Mos Treatment) | 91 | |
| Overall Study | COMPLETED | CTAP101 Capsules (Not Randomized; 12 Mos Treatment) | 130 | |
| Overall Study | COMPLETED | CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive | 39 | |
| Overall Study | NOT COMPLETED | CTAP101 Capsules (Not Randomized; 6 Mos Treatment) | 12 | |
| Overall Study | NOT COMPLETED | CTAP101 Capsules (Not Randomized; 12 Mos Treatment) | 23 | |
| Overall Study | NOT COMPLETED | CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive | 3 |
Source ClinicalTrials.gov
Adverse events264
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 | Anaemia | Blood and lymphatic system disorders | CTAP101 Capsules (Not Randomized; 6 Mos Treatment) | 7 | 103 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | CTAP101 Capsules (Not Randomized; 12 Mos Treatment) | 9 | 153 | 9 |
| other | Anaemia | Blood and lymphatic system disorders | CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive | 2 | 42 | 2 |
| other | Constipation | Gastrointestinal disorders | CTAP101 Capsules (Not Randomized; 6 Mos Treatment) | 7 | 103 | 7 |
| other | Constipation | Gastrointestinal disorders | CTAP101 Capsules (Not Randomized; 12 Mos Treatment) | 6 | 153 | 6 |
| other | Constipation | Gastrointestinal disorders | CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive | 0 | 42 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | CTAP101 Capsules (Not Randomized; 6 Mos Treatment) | 7 | 103 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | CTAP101 Capsules (Not Randomized; 12 Mos Treatment) | 6 | 153 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive | 1 | 42 | 1 |
| other | Nausea | Gastrointestinal disorders | CTAP101 Capsules (Not Randomized; 6 Mos Treatment) | 8 | 103 | 8 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CTAP101 Capsules (Not Randomized; 6 Mos Treatment) | ||
| Total, all-cause mortality | CTAP101 Capsules (Not Randomized; 12 Mos Treatment) | ||
| Total, all-cause mortality | CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive | ||
| Total, other adverse events | CTAP101 Capsules (Not Randomized; 6 Mos Treatment) | 36 | 103 |
| Total, other adverse events | CTAP101 Capsules (Not Randomized; 12 Mos Treatment) | 54 | 153 |
| Total, other adverse events | CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive | 22 | 42 |
| Total, serious adverse events | CTAP101 Capsules (Not Randomized; 6 Mos Treatment) | 18 | 103 |
| Total, serious adverse events | CTAP101 Capsules (Not Randomized; 12 Mos Treatment) | 33 | 153 |
| Total, serious adverse events | CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive | 9 | 42 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02282813
GET https://conductscience.org/api/trials/v1/NCT02282813/events?page=2