Chronic Kidney DiseasePhase 1NCT00792857
Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
A Phase 1 study testing CTAP201 Injection and Doxercalciferol in people with Chronic Kidney Disease and Secondary Hyperparathyroidism, run by OPKO IP Holdings II, Inc. at 6 sites in United States.
Trial summary
This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths. This study will also investigate the levels of CTAP201 in the body over time and determine the safety of CTAP201. 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?
- CTAP201 Injection and Doxercalciferol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2008to Oct 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 18 and 40
- On maintenance hemodialysis three times per week
- Visit 1: Serum iPTH value greater than or equal to 200 pg/mL and lower than or equal to 1000 pg/mL
- Visit 1: Serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
- Visit 1: 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 or equal to 15 ng/mL
Show all 9Show fewer
- Visit 2: Serum iPTH value greater than 300 pg/mL
- Visit 2: Serum Ca x P product less than 56 [mg/dl]2
- Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and length of study
Who cannot join
- Taking cytochrome P450 3A inhibitors and/or inducers
- Abnormal liver functions
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Northeast Clinical Research
Allentown, Pennsylvania, 18103-6379
University of Cincinnati
Cincinnati, Ohio, 45206
Southwest Houston Research Ltd.
Houston, Texas, 77099
Vanderbilt University
Nashville, Tennessee, 37232
Pivotal Reseach Centers
Peoria, Arizona, 85381
Western New England Renal and Transplant Associates
Springfield, Massachusetts, 01107
About this study
Official title: Single-Dose, Two-Period, Open Label, Dose Determination, Randomized, Cross-Over Study of CTAP201 Injection and Doxercalciferol (Hectorol) Injection in Subjects With Stage 5 CKD and SHPT on Hemodialysis
This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths. This study will also investigate the levels of CTAP201 in the body over time and determine the safety of CTAP201.
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure
- Being tested
- CTAP201 Injection, Doxercalciferol
- 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.
CTAP201 InjectionDrug
Comparison of different dose strengths of CTAP201 after single dose.
DoxercalciferolDrug
Also called Hectorol
Comparison of different dose strengths of doxercalciferol after single dose.
| Study group | Role | What they receive |
|---|---|---|
| CTAP201 Injection at dose a | Experimental | CTAP201 at dose a Receives: Drug: CTAP201 Injection |
| CTAP201 Injection | Experimental | CTAP201 at dose b or dose c Receives: Drug: CTAP201 Injection |
| Doxercalciferol at dose a | Active comparator | Active at dose a Receives: Drug: Doxercalciferol |
| Doxercalciferol | Active comparator | Active at dose b or dose c Receives: Drug: Doxercalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of CTAP201 and doxercalciferol
Measured: Day 1 and Day 15 of each dose level
Safety of a single dose of CTAP201 Injection
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2009
- Study completionOct 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT00792857
- Sponsor's protocol ID
- CTAP201-CL-1007
- Status last verified
- Nov 2009
- First submitted
- 14 Nov 2008
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose, Two-Period, Open Label, Dose Determination, Randomized, Cross-Over Study of CTAP201 Injection and Doxercalciferol (Hectorol) Injection in Subjects With Stage 5 CKD and SHPT on Hemodialysis
- ClinicalTrials.gov ID
- NCT00792857
- Acronym / sponsor ID
- CTAP201-CL-1007
- 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
- 24 participants (actual)
- Lead sponsor
- OPKO IP Holdings II, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 18 Nov 2008 (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 compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths. This study will also investigate the levels of CTAP201 in the body over time and determine the safety of CTAP201.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CTAP201 Injection at dose a | Experimental | Drug: CTAP201 InjectionCTAP201 at dose a |
| CTAP201 Injection | Experimental | Drug: CTAP201 InjectionCTAP201 at dose b or dose c |
| Doxercalciferol at dose a | Active comparator | Drug: DoxercalciferolActive at dose a |
| Doxercalciferol | Active comparator | Drug: DoxercalciferolActive at dose b or dose c |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Body mass index between 18 and 40
- On maintenance hemodialysis three times per week
- Visit 1: Serum iPTH value greater than or equal to 200 pg/mL and lower than or equal to 1000 pg/mL
- Visit 1: Serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
- Visit 1: 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 (2 listed)
- Taking cytochrome P450 3A inhibitors and/or inducers
- Abnormal liver functions
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 |
|---|---|---|
| CTAP201 InjectionComparison of different dose strengths of CTAP201 after single dose. | Drug | CTAP201 Injection, CTAP201 Injection at dose a |
| DoxercalciferolAlso: HectorolComparison of different dose strengths of doxercalciferol after single dose. | Drug | Doxercalciferol, Doxercalciferol at dose a |
Primary outcome
Blood levels of CTAP201 and doxercalciferol
Time frame: Day 1 and Day 15 of each dose level
Safety of a single dose of CTAP201 Injection
Time frame: Throughout the study
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 29 Sep 2014.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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
6 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 CTAP201 Injection and Doxercalciferol in people with Chronic Kidney Disease and Secondary Hyperparathyroidism, run by OPKO IP Holdings II, Inc. at 6 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 9 inclusion and 2 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 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Blood levels of CTAP201 and doxercalciferol (time frame: Day 1 and Day 15 of each dose level). 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 29 Sep 2014.