CKD Stage 3Phase 2NCT07494045
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants
A Phase 2 study testing CTAP101 in people with CKD Stage 3 and CKD Stage 4, run by OPKO Health, Inc. at 5 sites in United States.
Trial summary
The goal of this clinical trial is to evaluate safety, tolerability, and how CTAP101 Capsules work to treat Pediatric Participants with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- CKD Stage 3, CKD Stage 4, Secondary Hyperparathyroidism
- What is being tested?
- CTAP101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Aug 2026to Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Each participant must meet the following criteria to be enrolled in Cohort 1 of this study:
- Be 8 to <18 years of age with a body weight of ≥40 kg.
- Be diagnosed with stage 3 or 4 CKD at least six months prior to the screening visit (Visit 1) and have an eGFR of ≥15 to <60 mL/min/1.73m2 at screening.
- Be without any disease state or physical condition that might impair evaluation of safety or which, in the investigator's opinion, would interfere with study participation.
- Exhibit during the initial or, if necessary, a screening visit after washout:
- Plasma iPTH >85 pg/mL;
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- Serum Ca <9.8 mg/dL;
- Serum P ≤5.5 mg/dL; and
- Serum 25D <30 ng/mL.
- If taking calcitriol or other 1α-hydroxylated vitamin D therapy, be willing to forgo treatment with these agents for the duration of the study and complete a 2-week washout period prior to commencing treatment in the study.
- If receiving ≤2,000 IU/day or 50,000 IU/month (1,250 mcg) vitamin D supplementation (ergocalciferol or cholecalciferol) therapy, must agree to remain on a stable dose during the study.
- If taking >2,000 IU/day of vitamin D supplementation, must discontinue or decrease the dose to ≤2,000 IU/day, maintain that dose for the duration of the study and complete a 2-week washout period prior to commencing treatment in the study.
- If taking >1000 mg/day of elemental Ca through Ca-based phosphate binder or antacid therapy, must discontinue or decrease the dose to ≤ 1000 mg/day, maintain that dose for the duration of the study, and complete a 2-week washout period prior to commencing treatment in the study.
- If taking any bone metabolism therapy that could interfere with study endpoints, must discontinue use of such agent(s) for the duration of the study.
- Willing and able to comply with study procedures and instructions and commit to all study visits for the duration of the study.
- Willing and able to safely swallow the CTAP101 capsules whole.
- Female participants of childbearing potential must be neither pregnant nor lactating and must have a negative urine pregnancy test at the first screening visit.
- All female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use effective contraception (eg, implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study.
- Each participant or their legal representative must be able to read, understand and sign the ICF.
Who cannot join
- Participants who meet any of the following criteria will be excluded from the study:
- Kidney transplant within the 26 weeks preceding screening or kidney transplant rejection within the 26 weeks preceding screening.
- No history of parathyroidectomy or planned parathyroidectomy.
- History (prior three months) of serum Ca ≥9.8 mg/dL.
- Use of calcimimetic or calcifediol therapy within three months prior to consent.
- Use of bisphosphonate or denosumab therapy within six months prior to consent.
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- Known or suspected hypersensitivity to any of the constituents in CTAP101 Capsules.
- Known previous or concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease or cardiovascular event or hepatitis, or abnormal ECG or physical condition that in the opinion of the investigator may worsen and/or interfere with participation in the study.
- History of neurological/psychiatric disorder, including psychotic disorder, or any reason which, in the opinion of the investigator makes adherence to a treatment or FU schedule unlikely.
- Currently participating in, or has participated in, an interventional/investigational study within 30 days prior to study screening that in the opinion of the investigator and/or sponsor would interfere with the safety, assessments, and results of this study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
OPKO Site
Columbus, Ohio, 43205
Clinical Project Manager, 305-575-4000, contact@opko.com
- Recruiting
OPKO Site
Greenville, South Carolina, 29615
Clinical Project Manager, 305-575-4000, contact@opko.com
- Not yet recruiting
OPKO Site
Kansas City, Missouri, 64108
Clinical Project Manager, 305-575-4000, contact@opko.com
- Not yet recruiting
OPKO Site
Madison, Wisconsin, 53562
Clinical Project Manager, 305-575-4000, contact@opko.com
- Not yet recruiting
OPKO Site
Philadelphia, Pennsylvania, 19104
Clinical Project Manager, 305-575-4000, contact@opko.com
About this study
Official title: An Open-Label, Randomized, Multiple-Dose, Multi-Center Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of CTAP101 Extended-release Capsules in Pediatric Participants <18 Years of Age With Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency
The goal of this clinical trial is to evaluate safety, tolerability, and how CTAP101 Capsules work to treat Pediatric Participants with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency. The main questions it aims to answer are:
- To assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of CTAP101 Capsules
- To investigate the safety and tolerability of CTAP101 Capsules
Participants will take a daily dosage of CTAP101 Capsules at bedtime for 8 weeks.
- Conditions
- CKD Stage 3, CKD Stage 4, Secondary Hyperparathyroidism, VDI
- Being tested
- CTAP101
- Medical subject headings
- Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTAP101Drug
Capsules
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Group A | Experimental | 30 mcg CTAP101 Capsules Receives: Drug: CTAP101 |
| Cohort 1 - Group B | Experimental | 30 mcg or 60 mcg CTAP101 Capsules Receives: Drug: CTAP101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apparent clearance (CL/F)
To determine the CL/F of CTAP101 Capsules during and after repeated dosing
Measured: Up to 14 weeks
Volume of distribution (Vd/F)
To determine the Vd/F of CTAP101 Capsules during and after repeated dosing
Measured: Up to 14 weeks
Terminal elimination half-life (t1/2)
To determine the t1/2 of CTAP101 Capsules during and after repeated dosing
Measured: Up to 14 weeks
Incidence of treatment emergent adverse events (TEAE)
TEAEs will be graded as mild, moderate, severe.
Measured: Up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start5 Aug 2026
- Primary completionOct 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKD Stage 3Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494045
- Sponsor's protocol ID
- CTAP101-CL-2015
- Status last verified
- Aug 2026
- First submitted
- 20 Mar 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Multiple-Dose, Multi-Center Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of CTAP101 Extended-release Capsules in Pediatric Participants <18 Years of Age With Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency
- ClinicalTrials.gov ID
- NCT07494045
- Acronym / sponsor ID
- CTAP101-CL-2015
- Conditions
- CKD Stage 3, CKD Stage 4, Secondary Hyperparathyroidism, VDI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate safety, tolerability, and how CTAP101 Capsules work to treat Pediatric Participants with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency. The main questions it aims to answer are:
- To assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of CTAP101 Capsules
- To investigate the safety and tolerability of CTAP101 Capsules
Participants will take a daily dosage of CTAP101 Capsules at bedtime for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Group A | Experimental | Drug: CTAP10130 mcg CTAP101 Capsules |
| Cohort 1 - Group B | Experimental | Drug: CTAP10130 mcg or 60 mcg CTAP101 Capsules |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- Each participant must meet the following criteria to be enrolled in Cohort 1 of this study:
- Be 8 to <18 years of age with a body weight of ≥40 kg.
- Be diagnosed with stage 3 or 4 CKD at least six months prior to the screening visit (Visit 1) and have an eGFR of ≥15 to <60 mL/min/1.73m2 at screening.
- Be without any disease state or physical condition that might impair evaluation of safety or which, in the investigator's opinion, would interfere with study participation.
- Exhibit during the initial or, if necessary, a screening visit after washout:
Key exclusion criteria (10 listed)
- Kidney transplant within the 26 weeks preceding screening or kidney transplant rejection within the 26 weeks preceding screening.
- No history of parathyroidectomy or planned parathyroidectomy.
- History (prior three months) of serum Ca ≥9.8 mg/dL.
- Use of calcimimetic or calcifediol therapy within three months prior to consent.
- Use of bisphosphonate or denosumab therapy within six months prior to consent.
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 |
|---|---|---|
| CTAP101Capsules | Drug | Cohort 1 - Group A, Cohort 1 - Group B |
Primary outcome
Apparent clearance (CL/F)
Time frame: Up to 14 weeks
To determine the CL/F of CTAP101 Capsules during and after repeated dosing
Volume of distribution (Vd/F)
Time frame: Up to 14 weeks
To determine the Vd/F of CTAP101 Capsules during and after repeated dosing
Terminal elimination half-life (t1/2)
Time frame: Up to 14 weeks
To determine the t1/2 of CTAP101 Capsules during and after repeated dosing
Incidence of treatment emergent adverse events (TEAE)
Time frame: Up to 14 weeks
TEAEs will be graded as mild, moderate, severe.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CTAP101 in people with CKD Stage 3 and CKD Stage 4, run by OPKO Health, Inc. at 5 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 19 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact OPKO Health (305-575-4100, contact@opko.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apparent clearance (CL/F) (time frame: Up to 14 weeks). The study lists 4 primary outcomes in all. 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 20 Aug 2026.