Chronic Kidney DiseasePhase 3NCT02282813

Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002

A Phase 3 study testing CTAP101 Capsules, Calcitriol and Doxercalciferol in people with Chronic Kidney Disease and Hyperparathyroidism, Secondary, run by OPKO Health, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This extension study of subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 allows long term evaluation of the safety and efficacy of CTAP101 Capsules in reducing elevated intact parathyroid hormone (iPTH) and correcting vitamin D insufficiency in stage 3 or 4 chronic kidney disease patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
What is being tested?: CTAP101 Capsules, Calcitriol and Doxercalciferol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 298 participants
Where: No sites listed yet
Study dates: Apr 2013to May 2015
Phase: Phase 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Completed either of the phase 3 double-blind, placebo-controlled studies, CTAP101-CL-3001 or CTAP101-CL-3002
Taking no more than 1000 mg/day of elemental Ca and willing/able to remain on this dose for the duration of the study
Taking no more than 1600 IU/dose vitamin D (ergocalciferol or cholecalciferol) therapy and willing/able to remain on a stable dose of vitamin D during the study
Willing and able to comply with study instructions and to 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 a negative urine pregnancy test
All female subjects of childbearing potential and male subjects 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
Have the ability to read and understand subject Informed Consent Form (ICF). Subjects or their legal representatives must sign the ICF.

Who cannot join

Use of pharmacological dose of ergocalciferol and cholecalciferol (monthly equivalent of 50,000 IU or 1250 µg, eg, Drisdol®) or bisphosphonate therapy
Use of other bone metabolism therapy (with the exception of stable doses of bisphosphonates and denosumab [Xgeva® and Prolia®]) that may interfere with study endpoints
Concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease or cardiovascular event or hepatitis that in the opinion of the investigator may worsen and/or interfere with participation in the study
Neurological/psychiatric disorder, including psychotic disorder or dementia, or any condition 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 either investigational product (CTAP101) or adjunctive vitamin D hormone therapy

About this study

Official title: A Long-term Safety and Efficacy Study of CTAP101 Capsules in Subjects With Stages 3 or 4 Chronic Kidney Disease, Secondary Hyperparathyroidism and Vitamin D Insufficiency (Extension of Study CTAP101-CL-3001 or CTAP101-CL-3002)

Read the detailed description

Only subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 are eligible to participate in this extension study. This is a phase 3, open-label study of CTAP101 Capsules, with and without add-on vitamin D hormone therapy.

Conditions: Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
Being tested: CTAP101 Capsules, Calcitriol, Doxercalciferol, Paricalcitol
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, Vitamin D Deficiency, 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.

CTAP101 CapsulesDrug
Also called Calcifediol
At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily
CalcitriolDrug
Also called calcifediol
At week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily
DoxercalciferolDrug
Also called calcifediol
At week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily
ParicalcitolDrug
Also called calcifediol
At week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily

Study groups in NCT02282813
Study group	Role	What they receive
CTAP101 Capsules alone	Experimental	CTAP101 Capsules 30 or 60 mcg daily for up to 26 weeks Receives: Drug: CTAP101 Capsules
CTAP101 Capsules +calcitriol	Experimental	CTAP101 Capsules 60 mcg +calcitriol daily for 14 weeks Receives: Drug: CTAP101 Capsules; Drug: Calcitriol
CTAP101 Capsules +doxercalciferol	Experimental	CTAP101 Capsules 60 mcg +doxercalciferol daily for 14 weeks Receives: Drug: CTAP101 Capsules; Drug: Doxercalciferol
CTAP101 Capsules +paricalcitol	Experimental	CTAP101 Capsules 60 mcg +paricalcitol daily for 14 weeks Receives: Drug: CTAP101 Capsules; Drug: Paricalcitol

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
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
Measured: up to 6 months

Secondary outcomes (3)

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)
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
Measured: up to 6 months
Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT)
Number of Participants in the Intent to Treat Population with serum 25-hydroxyvitamin D >/= 30 ng/mL at End of Treatment (EOT)
Measured: up to 6 months
Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT)
Number of Participants in the per protocol population with serum 25-hydroxyvitamin D >/= 30 ng/mL at End of Treatment (EOT)
Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013May 2015

First posted4 Nov 2014 (estimated)
Study startApr 2013
Primary completionMay 2015
Study completionMay 2015

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 298 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02282813
Sponsor's protocol ID: CTAP101-CL-3003
Status last verified: Aug 2016
First submitted: 31 Oct 2014
Last updated: 29 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-term Safety and Efficacy Study of CTAP101 Capsules in Subjects With Stages 3 or 4 Chronic Kidney Disease, Secondary Hyperparathyroidism and Vitamin D Insufficiency (Extension of Study CTAP101-CL-3001 or CTAP101-CL-3002)
ClinicalTrials.gov ID: NCT02282813
Acronym / sponsor ID: CTAP101-CL-3003
Conditions: Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
Keywords: Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Kidney Diseases, Kidney Failure
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 298 participants (actual)
Lead sponsor: OPKO Health, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 4 Nov 2014 (estimated)
Results: Posted 17 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
CTAP101 Capsules alone	Experimental	Drug: CTAP101 CapsulesCTAP101 Capsules 30 or 60 mcg daily for up to 26 weeks
CTAP101 Capsules +calcitriol	Experimental	Drug: CTAP101 Capsules, Drug: CalcitriolCTAP101 Capsules 60 mcg +calcitriol daily for 14 weeks
CTAP101 Capsules +doxercalciferol	Experimental	Drug: CTAP101 Capsules, Drug: DoxercalciferolCTAP101 Capsules 60 mcg +doxercalciferol daily for 14 weeks
CTAP101 Capsules +paricalcitol	Experimental	Drug: CTAP101 Capsules, Drug: ParicalcitolCTAP101 Capsules 60 mcg +paricalcitol daily for 14 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Completed either of the phase 3 double-blind, placebo-controlled studies, CTAP101-CL-3001 or CTAP101-CL-3002
Taking no more than 1000 mg/day of elemental Ca and willing/able to remain on this dose for the duration of the study
Taking no more than 1600 IU/dose vitamin D (ergocalciferol or cholecalciferol) therapy and willing/able to remain on a stable dose of vitamin D during the study
Willing and able to comply with study instructions and to 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 a negative urine pregnancy test

Key exclusion criteria (5 listed)

Use of pharmacological dose of ergocalciferol and cholecalciferol (monthly equivalent of 50,000 IU or 1250 µg, eg, Drisdol®) or bisphosphonate therapy
Use of other bone metabolism therapy (with the exception of stable doses of bisphosphonates and denosumab [Xgeva® and Prolia®]) that may interfere with study endpoints
Concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease or cardiovascular event or hepatitis that in the opinion of the investigator may worsen and/or interfere with participation in the study
Neurological/psychiatric disorder, including psychotic disorder or dementia, or any condition 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 either investigational product (CTAP101) or adjunctive vitamin D hormone therapy

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
CTAP101 CapsulesAlso: CalcifediolAt week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily	Drug	CTAP101 Capsules +calcitriol, CTAP101 Capsules +doxercalciferol, CTAP101 Capsules +paricalcitol, CTAP101 Capsules alone
CalcitriolAlso: calcifediolAt week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily	Drug	CTAP101 Capsules +calcitriol
DoxercalciferolAlso: calcifediolAt week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily	Drug	CTAP101 Capsules +doxercalciferol
ParicalcitolAlso: calcifediolAt week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily	Drug	CTAP101 Capsules +paricalcitol

Primary outcome

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)
Time frame: 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

3 secondary outcomes

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)
Time frame: up to 6 months
Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT)
Time frame: up to 6 months
Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT)
Time frame: up to 6 months

Results and safety

Results posted to the registry on 17 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CTAP101 Capsules (Not Randomized; 6 Mos Treatment)	103	91
CTAP101 Capsules (Not Randomized; 12 Mos Treatment)	153	130
CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive	42	39

Primary outcome: 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)

Time frame: up to 6 months. Number. Unit: participants

Measure	CTAP101 Capsules (Not Randomized; 6 Mos Treatment) n = 103	CTAP101 Capsules (Not Randomized; 12 Mos Treatment) n = 153	CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive n = 42
Value	34	66	30

CTAP101 Capsules (Not Randomized; 6 Mos Treatment) vs CTAP101 Capsules (Not Randomized; 12 Mos Treatment): p = 0.1041, Cochran-Mantel-Haenszel

Population analysed: Intent to treat

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months from initiation of treatment through end of treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CTAP101 Capsules (Not Randomized; 6 Mos Treatment)	18 of 103 (17.5%)	36 of 103 (35%)	Not reported
CTAP101 Capsules (Not Randomized; 12 Mos Treatment)	33 of 153 (21.6%)	54 of 153 (35.3%)	Not reported
CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive	9 of 42 (21.4%)	22 of 42 (52.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 Renal

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CTAP101 Capsules, Calcitriol and Doxercalciferol in people with Chronic Kidney Disease and Hyperparathyroidism, Secondary, run by OPKO Health, Inc..

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 5 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 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

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 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 17 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?

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) (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02282813.

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 29 Sep 2016.