A Phase 4 interventional study of Calcifediol Oral Capsule and Calcifediol Oral Product in Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency and CKD Stage 3, sponsored by OPKO Health, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-09.
Sponsored by OPKO Health, Inc. · Phase 4, Interventional, and Treatment
An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency
OPKO Health, Inc. is the lead sponsor of 49 studies on the registry; 2 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
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.
Be without any disease state or physical condition that might impair evaluation of safety and efficacy or which, in the Investigator's opinion, would interfere with study participation, including:
Exhibit during the initial screening visit:
Exhibit after the 4-week washout period (if required):
Exclusion Criteria:
CTAP101/Calcifediol Capsules 60 micrograms (mcg) once daily at bedtime, except on Days 1 and 29 when dosing will occur in the morning before breakfast
Drug: Calcifediol Oral Capsule
Immediate-release (IR) calcifediol/266 micrograms (mcg) capsule before breakfast on the mornings of Day 1 and Day 29
Drug: Calcifediol Oral Product
Cholecalciferol/Capsules 300,000 International Units (IU) (high-dose) before breakfast on the mornings of Day 1 and Day 29
Drug: Cholecalciferol
Paricalcitol/Capsules 1 mcg plus cholecalciferol capsules 800 IU (low-dose) once daily in the morning before breakfast, except on Days 1 and29 when dosing will occur before breakfast
Drug: Cholecalciferol · Drug: Paricalcitol Oral Capsule
Capsule, daily
Also known as: CTAP101
Capsule, once a month
Capsule, once a month
Capsule, daily
Incidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
This study is descriptive and no primary or secondary efficacy endpoints are defined.
Time frame: 5 months
| Milestone | CTAP101 | Immediate-release (IR) Calcifediol | Cholecalciferol | Paricalcitol |
|---|---|---|---|---|
| Started | 18 | 18 | 18 | 15 |
| Completed | 18 | 15 | 15 | 14 |
| Not completed | 0 | 3 | 3 | 1 |
This study is descriptive and no primary or secondary efficacy endpoints are defined.
| number of TEAE count | CTAP101 | Immediate-release (IR) Calcifediol | Cholecalciferol | Paricalcitol |
|---|---|---|---|---|
| Grade 1 Mild | 39 | 12 | 13 | 10 |
| Grade 2 Moderate | 1 | 3 | 8 | 5 |
| Grade 3 Severe | 2 | 3 | 0 | 1 |
| Grade Potentially Life Threatening | 0 | 0 | 0 | 0 |
| Grade 5 Fatal | 0 | 0 | 0 | 0 |
Collected over 5 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CTAP101 | 0/18 (0%) | 1/18 (5.6%) | 7/18 (38.9%) |
| Immediate-release (IR) Calcifediol | 0/18 (0%) | 2/18 (11.1%) | 7/18 (38.9%) |
| Cholecalciferol | 0/18 (0%) | 4/18 (22.2%) | 8/18 (44.4%) |
| Paricalcitol | 0/15 (0%) | 1/15 (6.7%) | 8/15 (53.3%) |
| Event | CTAP101 | Immediate-release (IR) Calcifediol | Cholecalciferol | Paricalcitol |
|---|---|---|---|---|
| Lumbar radiculopathyNervous system disorders | 0/18 | 0/18 | 0/18 | 1/15 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/18 | 0/18 | 0/18 | 1/15 |
| Lumbar spinal stenosisMusculoskeletal and connective tissue disorders | 0/18 | 0/18 | 0/18 | 1/15 |
| MelaenaGastrointestinal disorders | 0/18 | 1/18 | 0/18 | 0/15 |
| Rectal haemorrhageGastrointestinal disorders | 1/18 | 0/18 | 0/18 | 0/15 |
| Hypertensive encephalopathyNervous system disorders | 0/18 | 0/18 | 1/18 | 0/15 |
| QuadrantanopiaNervous system disorders | 0/18 | 0/18 | 1/18 | 0/15 |
| Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 0/18 | 1/18 | 0/18 | 0/15 |
| Pulmonary oedemaRespiratory, thoracic and mediastinal disorders | 0/18 | 0/18 | 1/18 | 0/15 |
| CholecystitisHepatobiliary disorders | 0/18 | 0/18 | 1/18 | 0/15 |
| Event | CTAP101 | Immediate-release (IR) Calcifediol | Cholecalciferol | Paricalcitol |
|---|---|---|---|---|
| HeadacheNervous system disorders | 2/18 | 2/18 | 0/18 | 2/15 |
| DiarrhoeaGastrointestinal disorders | 2/18 | 1/18 | 1/18 | 1/15 |
| LacerationInjury, poisoning and procedural complications | 0/18 | 0/18 | 2/18 | 0/15 |
| NauseaGastrointestinal disorders | 1/18 | 0/18 | 1/18 | 1/15 |
| DyspepsiaGastrointestinal disorders | 0/18 | 0/18 | 0/18 | 1/15 |
| Lumbar radiculopathyNervous system disorders | 0/18 | 0/18 | 0/18 | 1/15 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 0/18 | 0/18 | 0/18 | 1/15 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/18 | 0/18 | 1/18 | 1/15 |
| Joint swellingMusculoskeletal and connective tissue disorders | 1/18 | 0/18 | 0/18 | 1/15 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/18 | 0/18 | 0/18 | 1/15 |
| Age, Continuous(Year) | CTAP101 | Immediate-release (IR) Calcifediol | Cholecalciferol | Paricalcitol | Total |
|---|---|---|---|---|---|
| Mean | 67.1 ± 10.7 | 70.1 ± 14.4 | 67.9 ± 9.8 | 63.4 ± 12.0 | 67.3 ± 11.8 |
| Sex: Female, Male(Participants) | CTAP101 | Immediate-release (IR) Calcifediol | Cholecalciferol | Paricalcitol | Total |
|---|---|---|---|---|---|
| Female | 11 | 6 | 5 | 10 | 32 |
| Male | 7 | 12 | 13 | 5 | 37 |
| Ethnicity (NIH/OMB)(Participants) | CTAP101 | Immediate-release (IR) Calcifediol | Cholecalciferol | Paricalcitol | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 1 | 1 | 4 |
| Not Hispanic or Latino | 17 | 17 | 17 | 14 | 65 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Ran from Jun 2018 to primary completion in Apr 2020, 22 months.
Results were first posted in Dec 2022, 2 years 7 months after primary completion. A results delay was requested in Apr 2021.
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Studies of the drugs tested here: Calcifediol · Cholecalciferol