Chronic Kidney DiseasePhase 2/3NCT01219855
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
A Phase 2/3 study testing Cohort 1 CTAP101 Capsules- 60µg, Cohort 1 CTAP101 Capsules - 90µg and Cohort 1 Matching Sugar Capsule in people with Chronic Kidney Disease and Secondary Hyperparathyroidism, run by OPKO Health, Inc. at 1 site in United States.
Trial summary
This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Vitamin D Insufficiency
- What is being tested?
- Cohort 1 CTAP101 Capsules- 60µg, Cohort 1 CTAP101 Capsules - 90µg and Cohort 1 Matching Sugar Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Nov 2011
- Phase
- Phase 2/3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urinary albumin excretion of ≤3000 μg of creatinine
- Stage 3 CKD
- Plasma iPTH: > 70 pg/mL and < 500 pg/mL
- Serum Ca: ≥ 8.4 mg/dL and < 10.0 mg/dL
- Serum P: ≥ 2.0 mg/dL and < 5.0 mg/dL
- Serum 25-hydroxyvitamin D: > 10 ng/mL and < 29 ng/mL.
- Discontinue vitamin D use for duration of study
Who cannot join
- History of kidney transplant or parathyroidectomy
- Spot urine calcium:creatinine ratio > 0.2
- Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis
- Currently on dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled, Repeat Dose, Safety, Efficacy and Pharmacokinetic/Pharmacodynamic Study of CTAP101 Capsules in Subjects With Chronic Kidney Disease, Vitamin D Insufficiency and Secondary Hyperparathyroidism
This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
- Being tested
- Cohort 1 CTAP101 Capsules- 60µg, Cohort 1 CTAP101 Capsules - 90µg, Cohort 1 Matching Sugar Capsule, Cohort 2 CTAP101 Capsules - 30µg, Cohort 2 Matching Sugar Capsule
- Keywords
- Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Kidney Diseases, Kidney Failure, Renal Insufficiency, Chronic
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary, Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1 CTAP101 Capsules- 60µgDrug
60µg of CTAP101 capsules given once daily for 42 days.
Cohort 1 CTAP101 Capsules - 90µgDrug
90µg of CTAP101 capsules given once daily for 42 days.
Cohort 1 Matching Sugar CapsuleDrug
Placebo capsules given once daily for 42 days.
Cohort 2 CTAP101 Capsules - 30µgDrug
30µg of CTAP101 capsules given once daily for 42 days.
Cohort 2 Matching Sugar CapsuleDrug
Placebo capsules given once daily for 42 days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: CTAP101 Capsules 60µg | Experimental | Not described Receives: Drug: Cohort 1 CTAP101 Capsules- 60µg |
| Cohort 1: CTAP101 Capsules 90µg | Experimental | Not described Receives: Drug: Cohort 1 CTAP101 Capsules - 90µg |
| Cohort 1: Sugar Capsule | Placebo comparator | Not described Receives: Drug: Cohort 1 Matching Sugar Capsule |
| Cohort 2: CTAP101 Capsules 30µg | Experimental | Not described Receives: Drug: Cohort 2 CTAP101 Capsules - 30µg |
| Cohort 2: Sugar Capsule | Placebo comparator | Not described Receives: Drug: Cohort 2 Matching Sugar Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP).
The proportion of subjects in the per protocol population with serum 25-hydroxyvitamin D ≥30 ng/mL at End-of-Treatment (EOT; Week 6) in Cohorts 1 and 2 (60/90 and 30 μg groups, respectively) were compared to their corresponding placebo groups.
Measured: 6 weeks
Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population)
Mean percent change from baseline in plasma intact parathyroid hormone (iPTH) from baseline to End of Treatment (EOT) in the Per Protocol population. Subjects in Cohorts 1 and 2 (dose regimens 60/90 and 30 mcg, respectively) were compared to their respective placebo groups.
Measured: 6 weeks
Secondary outcomes (4)
Change From Baseline in Serum 25-hydroxyvitamin D at Week 6
Mean absolute change from baseline in serum total 25-hydroxyvitamin D to end of treatment (EOT)
Measured: Baseline to End of Treatment (6 weeks)
Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population
Mean percent change from baseline in serum 25-hydroxyvitamin D at End of Treatment (EOT, week 6) in the per protocol population. Subjects in Cohorts 1 and 2 (dose regimens of 60/90 and 30 mcg, respectively) were compared versus their corresponding placebo groups.
Measured: Baseline to End of Treatment (6 weeks)
Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6
Proportion of subjects with at least 30% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)
Measured: Baseline to End of Treatment (6 weeks)
Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6
Proportion of subjects with at least 20% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)
Measured: Baseline to End of Treatment (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2011
- Study completionNov 2011
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 Chronic Kidney DiseaseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Melnick, MD, Study director, OPKO Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219855
- Sponsor's protocol ID
- CTAP101-CL-2008
- Status last verified
- Sep 2014
- First submitted
- 11 Oct 2010
- Last updated
- 25 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled, Repeat Dose, Safety, Efficacy and Pharmacokinetic/Pharmacodynamic Study of CTAP101 Capsules in Subjects With Chronic Kidney Disease, Vitamin D Insufficiency and Secondary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT01219855
- Acronym / sponsor ID
- CTAP101-CL-2008
- Keywords
- Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Kidney Diseases, Kidney Failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Posted 25 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: CTAP101 Capsules 60µg | Experimental | Drug: Cohort 1 CTAP101 Capsules- 60µg |
| Cohort 1: CTAP101 Capsules 90µg | Experimental | Drug: Cohort 1 CTAP101 Capsules - 90µg |
| Cohort 1: Sugar Capsule | Placebo comparator | Drug: Cohort 1 Matching Sugar Capsule |
| Cohort 2: CTAP101 Capsules 30µg | Experimental | Drug: Cohort 2 CTAP101 Capsules - 30µg |
| Cohort 2: Sugar Capsule | Placebo comparator | Drug: Cohort 2 Matching Sugar Capsule |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Urinary albumin excretion of ≤3000 μg of creatinine
- Stage 3 CKD
- Plasma iPTH: > 70 pg/mL and < 500 pg/mL
- Serum Ca: ≥ 8.4 mg/dL and < 10.0 mg/dL
- Serum P: ≥ 2.0 mg/dL and < 5.0 mg/dL
Key exclusion criteria (4 listed)
- History of kidney transplant or parathyroidectomy
- Spot urine calcium:creatinine ratio > 0.2
- Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis
- Currently on dialysis
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 |
|---|---|---|
| Cohort 1 CTAP101 Capsules- 60µg60µg of CTAP101 capsules given once daily for 42 days. | Drug | Cohort 1: CTAP101 Capsules 60µg |
| Cohort 1 CTAP101 Capsules - 90µg90µg of CTAP101 capsules given once daily for 42 days. | Drug | Cohort 1: CTAP101 Capsules 90µg |
| Cohort 1 Matching Sugar CapsulePlacebo capsules given once daily for 42 days. | Drug | Cohort 1: Sugar Capsule |
| Cohort 2 CTAP101 Capsules - 30µg30µg of CTAP101 capsules given once daily for 42 days. | Drug | Cohort 2: CTAP101 Capsules 30µg |
| Cohort 2 Matching Sugar CapsulePlacebo capsules given once daily for 42 days. | Drug | Cohort 2: Sugar Capsule |
Primary outcome
Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP).
Time frame: 6 weeks
The proportion of subjects in the per protocol population with serum 25-hydroxyvitamin D ≥30 ng/mL at End-of-Treatment (EOT; Week 6) in Cohorts 1 and 2 (60/90 and 30 μg groups, respectively) were compared to their corresponding placebo groups.
Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population)
Time frame: 6 weeks
Mean percent change from baseline in plasma intact parathyroid hormone (iPTH) from baseline to End of Treatment (EOT) in the Per Protocol population. Subjects in Cohorts 1 and 2 (dose regimens 60/90 and 30 mcg, respectively) were compared to their respective placebo groups.
4 secondary outcomes
Change From Baseline in Serum 25-hydroxyvitamin D at Week 6
Time frame: Baseline to End of Treatment (6 weeks)
Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population
Time frame: Baseline to End of Treatment (6 weeks)
Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6
Time frame: Baseline to End of Treatment (6 weeks)
Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6
Time frame: Baseline to End of Treatment (6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Joel Melnick, MD study director
OPKO Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cohort 1 CTAP101 Capsules- 60µg, Cohort 1 CTAP101 Capsules - 90µg and Cohort 1 Matching Sugar Capsule in people with Chronic Kidney Disease and Secondary Hyperparathyroidism, run by OPKO Health, Inc. at 1 site 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 7 inclusion and 4 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 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 25 Aug 2016). 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?
Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP). (time frame: 6 weeks). The study lists 2 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 25 Aug 2016.