Chronic Kidney DiseasePhase 1NCT00888069
Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects
A Phase 1 study testing CTAP101 Capsules and CTAP101 Injection in people with Chronic Kidney Disease and Secondary Hyperparathyroidism, run by OPKO IP Holdings II, Inc. at 12 sites in United States.
Trial summary
This study will investigate how the levels of a single 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 Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency
- What is being tested?
- CTAP101 Capsules and CTAP101 Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2009to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index between great than or equal to 18 and less than or equal to 40 kg/m2
- Plasma iPTH value for Stage 3 CKD greater than or equal to 70 pg/mL and lower than or equal to 1000 pg/mL
- Plasma iPTH value for Stage 4 CKD greater than or equal to 110 pg/mL and lower than or equal to 1000 pg/mL
- Adjusted serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
- Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL
- Serum 25-hydroxyvitamin D level greater than 15 ng/mL and lower than 30 ng/mL
- Hemoglobin level greater than or equal to 10 g/dL
Who cannot join
- Has nephrotic range proteinuria
- Has liver disease or significant hepatic dysfunction
- Is taking Cytochrome P450 3A4 inhibitors or inducers
- Has adult history of kidney stones and dysphagia
- Has known history of alcohol/controlled substance abuse or are positive for drug of abuse screen
- Currently on dialysis
- Current serious illness such as cancer, HIV, cardiovascular event or hepatitis
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Northeast Clinical Research
Allentown, Pennsylvania, 18103
Twin Cities Clinical Research
Brooklyn Center, Minnesota, 55430
Southeast Renal Research Institute
Chattanooga, Tennessee, 37404
DCI
Cincinnati, Ohio, 45206
MetroHealth Medical Center
Cleveland, Ohio, 44109-1998
Purity Dialysis Centers / Nephrology Associates
Delafield, Wisconsin, 53018
Research by Design
Evergreen Park, Illinois, 60805
Southwest Houston Research Ltd
Houston, Texas, 77099
Gunderson Clinic Ltd.
La Crosse, Wisconsin, 54601
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Pivotal Research Centers
Peoria, Arizona, 85381
Western New England Renal & Transplant Associates
Springfield, Massachusetts, 01107
About this study
Official title: A Randomized, Open-Label, Single-Dose Pilot Study of Oral and i.v. CTAP101 Evaluating PK and Safety in Stage 3 and 4 CKD Subjects With Vitamin D Insufficiency and SHPT
This study will investigate how the levels of a single 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 Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure
- Being tested
- CTAP101 Capsules, CTAP101 Injection
- Keywords
- Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Renal Insufficiency, Chronic, Kidney Diseases, Kidney Failure
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary, Kidney Failure, Chronic, Parathyroid Diseases, Renal Insufficiency, Hyperparathyroidism, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTAP101 CapsulesDrug
Single dose oral administration
CTAP101 InjectionDrug
single IV injection
| Study group | Role | What they receive |
|---|---|---|
| Low Dose CTAP101 Capsules | Experimental | CTAP101 Capsules, 450 mcg dose Receives: Drug: CTAP101 Capsules |
| High Dose CTAP101 Capsules | Experimental | CTAP101 Capsules, 900 mcg dose Receives: Drug: CTAP101 Capsules |
| CTAP101 Injection | Experimental | IV injection, 448 mcg dose Receives: Drug: CTAP101 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT
Measured: from 3 to 0 hours prior to dosing until 42 days post dosing
Secondary outcomes (2)
To assess the safety and tolerability of CTAP101 capsules and injection
Measured: From signing of ICF (Day -35) through study completion (Day 42 post dosing)
To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT.
Measured: From signing of ICF (Day -35) through study completion (Day 42 post dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO IP Holdings II, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Melnick, MD, Study director, OPKO Renal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888069
- Sponsor's protocol ID
- CTAP101-CL-2004
- Status last verified
- Feb 2010
- First submitted
- 23 Apr 2009
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Single-Dose Pilot Study of Oral and i.v. CTAP101 Evaluating PK and Safety in Stage 3 and 4 CKD Subjects With Vitamin D Insufficiency and SHPT
- ClinicalTrials.gov ID
- NCT00888069
- Acronym / sponsor ID
- CTAP101-CL-2004
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure
- Keywords
- Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Renal Insufficiency, Chronic, Kidney Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- OPKO IP Holdings II, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Apr 2009 (estimated)
- 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.
This study will investigate how the levels of a single 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 Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose CTAP101 Capsules | Experimental | Drug: CTAP101 CapsulesCTAP101 Capsules, 450 mcg dose |
| High Dose CTAP101 Capsules | Experimental | Drug: CTAP101 CapsulesCTAP101 Capsules, 900 mcg dose |
| CTAP101 Injection | Experimental | Drug: CTAP101 InjectionIV injection, 448 mcg dose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Body mass index between great than or equal to 18 and less than or equal to 40 kg/m2
- Plasma iPTH value for Stage 3 CKD greater than or equal to 70 pg/mL and lower than or equal to 1000 pg/mL
- Plasma iPTH value for Stage 4 CKD greater than or equal to 110 pg/mL and lower than or equal to 1000 pg/mL
- Adjusted serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
- Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL
Key exclusion criteria (7 listed)
- Has nephrotic range proteinuria
- Has liver disease or significant hepatic dysfunction
- Is taking Cytochrome P450 3A4 inhibitors or inducers
- Has adult history of kidney stones and dysphagia
- Has known history of alcohol/controlled substance abuse or are positive for drug of abuse screen
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 CapsulesSingle dose oral administration | Drug | High Dose CTAP101 Capsules, Low Dose CTAP101 Capsules |
| CTAP101 Injectionsingle IV injection | Drug | CTAP101 Injection |
Primary outcome
To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT
Time frame: from 3 to 0 hours prior to dosing until 42 days post dosing
2 secondary outcomes
To assess the safety and tolerability of CTAP101 capsules and injection
Time frame: From signing of ICF (Day -35) through study completion (Day 42 post dosing)
To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT.
Time frame: From signing of ICF (Day -35) through study completion (Day 42 post dosing)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
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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
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTAP101 Capsules and CTAP101 Injection in people with Chronic Kidney Disease and Secondary Hyperparathyroidism, run by OPKO IP Holdings II, Inc. at 12 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 7 inclusion and 7 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 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT (time frame: from 3 to 0 hours prior to dosing until 42 days post dosing). 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 30 Sep 2014.