Secondary Hyperparathyroidism Due to Renal CausesPhase 4NCT03588884
Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency
A Phase 4 study testing Calcifediol Oral Capsule, Calcifediol Oral Product and Cholecalciferol in people with Secondary Hyperparathyroidism Due to Renal Causes and Vitamin D Insufficiency, run by OPKO Health, Inc. at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency, CKD Stage 3
- What is being tested?
- Calcifediol Oral Capsule, Calcifediol Oral Product and Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Jun 2018to 24 Apr 2020
- Phase
- Phase 4
- 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
- Be at least 18 years of age.
- Have stage 3 or 4 CKD (estimated glomerular filtration rate [eGFR] of ≥15 to <60 millilter per minute per 1.73 meter square (mL/min/1.73 m2) using the Modification of Diet in Renal Disease equation).
- 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:
- Serum albumin ≤ 3.0 (grams per deciliter (g/dL);
- Serum transaminase (alanine transaminase, glutamic pyruvic transaminase, aspartate aminotransferase or glutamic oxaloacetic transaminase) > 2.5 times the upper limit of normal at screening; and,
- Urinary albumin excretion ≤3000 microgram per milligram (μg/mg) creatinine.
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- Exhibit during the initial screening visit:
- Plasma intact parathyroid hormone (iPTH) ≥70 picogram per milliliter (pg/mL) and <400 pg/mL if receiving calcitriol or other 1α- hydroxylated vitamin D analog (paricalcitol or doxercalciferol); or
- Plasma iPTH ≥100 pg/mL and <500 pg/mL if not receiving calcitriol or other 1α- hydroxylated vitamin D analog; and,
- Serum total 25-hydroxyvitamin D <30 nanogram per milliliter (ng/mL).
- If taking calcitriol, other 1α-hydroxylated vitamin D analog, or vitamin D supplementation, must forgo treatment with these non-study agents for the duration of the study and undergo a 4-week washout period.
- Exhibit after the 4-week washout period (if required):
- Plasma iPTH ≥100 pg/mL and <500 pg/mL;
- Corrected serum calcium <9.8 mg/dL; (corrected for serum albumin)
- Serum total 25-hydroxyvitamin D <30 nanogram per milliliter (ng/mL); and,
- Serum phosphorus <5.5 milligram per deciliter (mg/dL).
- If taking more than 1,500 milligram per day (mg/day) of elemental calcium, reduce calcium use (to approximately 1,000 to ≤1,500 mg/day) for the duration of the study.
- Willing and able to comply with study instructions and commit to all clinic visits for the duration of the study.
- Female subjects of childbearing potential must be neither pregnant nor lactating and must have negative blood pregnancy tests at the first screening visit.
- All female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective contraception (implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study.
- Be able to read, understand and sign the subject Informed Consent Form (ICF) or have a legal authorized representative (LAR) sign the ICF.
Who cannot join
- History of or planned kidney transplant or parathyroidectomy
- History (prior 3 months) of corrected serum calcium ≥9.8 mg/dL or serum phosphorus ≥5.5 mg/dL if not receiving calcitriol or other 1α-hydroxylated vitamin D analog.
- Need for phosphate binders to maintain the serum phosphate < 5.5 mg/dL or use of phosphate binders within 4 weeks prior to screening
- Use of calcimimetic therapy (cinacalcet or etelcalcetide) within 12 weeks of screening.
- Receipt of bisphosphonate therapy or other bone modifying treatment within 6 months prior to enrollment.
- Known previous or concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease, intestinal malabsorption disorder, hepatitis or cardiovascular event that in the opinion of the Investigator may worsen or reduce life expectancy, and/or interfere with participation in the study.
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- History of neurological/psychiatric disorder, including psychotic disorder or dementia, or any reason which, in the opinion of the Investigator makes adherence to a treatment or follow-up schedule unlikely.
- Known or suspected hypersensitivity to any of the constituents of the study drugs.
- Currently participating in, or has participated in, an interventional/investigational study within 30 days prior to study screening.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research by Design, LLC
Chicago, Illinois, 60643
National Institute of Clinical Research, Inc.
Garden Grove, California, 92844
Spaulding Clinical Research
West Bend, Wisconsin, 53095
About this study
Official title: 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
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
- Conditions
- Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency, CKD Stage 3, CKD Stage 4
- Being tested
- Calcifediol Oral Capsule, Calcifediol Oral Product, Cholecalciferol, Paricalcitol Oral Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcifediol Oral CapsuleDrug
Also called CTAP101
Capsule, daily
Calcifediol Oral ProductDrug
Capsule, once a month
CholecalciferolDrug
Capsule, once a month
Paricalcitol Oral CapsuleDrug
Capsule, daily
| Study group | Role | What they receive |
|---|---|---|
| CTAP101 | Active comparator | 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 Receives: Drug: Calcifediol Oral Capsule |
| Immediate-release (IR) calcifediol | Experimental | Immediate-release (IR) calcifediol/266 micrograms (mcg) capsule before breakfast on the mornings of Day 1 and Day 29 Receives: Drug: Calcifediol Oral Product |
| Cholecalciferol | Experimental | Cholecalciferol/Capsules 300,000 International Units (IU) (high-dose) before breakfast on the mornings of Day 1 and Day 29 Receives: Drug: Cholecalciferol |
| Paricalcitol | Active comparator | 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 Receives: Drug: Cholecalciferol; Drug: Paricalcitol Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start8 Jun 2018
- Primary completion24 Apr 2020
- Study completion24 Apr 2020
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 Secondary Hyperparathyroidism Due to Renal CausesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588884
- Sponsor's protocol ID
- CTAP101-CL-4001
- Status last verified
- Nov 2022
- First submitted
- 28 Jun 2018
- Last updated
- 9 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03588884
- Acronym / sponsor ID
- CTAP101-CL-4001
- Conditions
- Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency, CKD Stage 3, CKD Stage 4
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 24 Apr 2020 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 17 Jul 2018 (actual)
- Results
- Posted 9 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CTAP101 | Active comparator | Drug: Calcifediol Oral CapsuleCTAP101/Calcifediol Capsules 60 micrograms (mcg) once daily at bedtime, except on Days 1 and 29 when dosing will occur in the morning before breakfast |
| Immediate-release (IR) calcifediol | Experimental | Drug: Calcifediol Oral ProductImmediate-release (IR) calcifediol/266 micrograms (mcg) capsule before breakfast on the mornings of Day 1 and Day 29 |
| Cholecalciferol | Experimental | Drug: CholecalciferolCholecalciferol/Capsules 300,000 International Units (IU) (high-dose) before breakfast on the mornings of Day 1 and Day 29 |
| Paricalcitol | Active comparator | Drug: Cholecalciferol, Drug: Paricalcitol Oral CapsuleParicalcitol/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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Be at least 18 years of age.
- Have stage 3 or 4 CKD (estimated glomerular filtration rate [eGFR] of ≥15 to <60 millilter per minute per 1.73 meter square (mL/min/1.73 m2) using the Modification of Diet in Renal Disease equation).
- 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:
- If taking calcitriol, other 1α-hydroxylated vitamin D analog, or vitamin D supplementation, must forgo treatment with these non-study agents for the duration of the study and undergo a 4-week washout period.
Key exclusion criteria (9 listed)
- History of or planned kidney transplant or parathyroidectomy
- History (prior 3 months) of corrected serum calcium ≥9.8 mg/dL or serum phosphorus ≥5.5 mg/dL if not receiving calcitriol or other 1α-hydroxylated vitamin D analog.
- Need for phosphate binders to maintain the serum phosphate < 5.5 mg/dL or use of phosphate binders within 4 weeks prior to screening
- Use of calcimimetic therapy (cinacalcet or etelcalcetide) within 12 weeks of screening.
- Receipt of bisphosphonate therapy or other bone modifying treatment within 6 months prior to enrollment.
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 |
|---|---|---|
| Calcifediol Oral CapsuleAlso: CTAP101Capsule, daily | Drug | CTAP101 |
| Calcifediol Oral ProductCapsule, once a month | Drug | Immediate-release (IR) calcifediol |
| CholecalciferolCapsule, once a month | Drug | Cholecalciferol, Paricalcitol |
| Paricalcitol Oral CapsuleCapsule, daily | Drug | Paricalcitol |
Primary outcome
Incidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Time frame: 5 months
This study is descriptive and no primary or secondary efficacy endpoints are defined.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Secondary Hyperparathyroidism Due to Renal Causes
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Secondary Hyperparathyroidism Due to Renal Causes, End Stage Renal Failure
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcifediol Oral Capsule, Calcifediol Oral Product and Cholecalciferol in people with Secondary Hyperparathyroidism Due to Renal Causes and Vitamin D Insufficiency, run by OPKO Health, Inc. at 3 sites 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 21 inclusion and 9 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 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 9 Dec 2022). 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?
Incidence and Severity of Treatment-Emergent Adverse Events (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. (time frame: 5 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 9 Dec 2022.