Chronic Kidney DiseasePhase 2NCT00742716
Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
A Phase 2 study testing CTA018 Injection in people with Chronic Kidney Disease and Secondary Hyperparathyroidism, run by OPKO IP Holdings II, Inc. at 12 sites in 2 countries.
Trial summary
This study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK) in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis. 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?
- CTA018 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Oct 2008to Jun 2010
- Phase
- Phase 2
- 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 35
- On maintenance hemodialysis three times per week
- Serum iPTH value greater than or equal to 300 pg/mL and lower than or equal to 1000 pg/mL
- Adjusted or total serum calcium value greater than or equal to 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 or equal to 15 ng/mL
- Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and the length of study
Who cannot join
- On bisphosphonates for at least three months prior to first dose of Study Drug
- Currently taking cytochrome P450 3A inhibitors and/or inducers
- Abnormal liver functions
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Canada7 sites
Hôpital Charles-Lemoyne
Greenfield Park, Quebec, J4V 2H1
Capital District Heatlth Authority: Centre for Clinical Research
Halifax, Nova Scotia, B3H 1V8
St. Joseph's Health Care London
London, Ontario, N6A 4V2
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5
St. Michael's Hospital
Toronto, Ontario, M5N 1W8
Hospital de Verdun
Verdun, Quebec, H4G 2A3
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
United States5 sites
Southeast Renal Research Institute
Chattanooga, Tennessee, 37404
U.S. Renal Care
Fort Worth, Texas, 76105
Boise Kidney and Hypertension Institute
Meridian, Idaho, 83642
Pines Clinical Research, Inc.
Pembroke Pines, Florida, 33028
Western New England Renal & Transplant Associates (WNERTA)
Springfield, Massachusetts, 01107-1121
About this study
Official title: An Open Label, Four Week, Dose Escalating Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Study of CTA018 Injection in Subjects With Stage 5 Chronic Kidney Disease With Secondary Hyperparathyroidism on Hemodialysis
This study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK) in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis. This study will also investigate the safety and effects of different strengths of CTA018, on parathyroid hormone (PTH) levels.
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure
- Being tested
- CTA018 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.
CTA018 InjectionDrug
Comparison of different dosages of drug
| Study group | Role | What they receive |
|---|---|---|
| CTA018 Injection low dose | Experimental | Low dose IV 3 times a week for 4 weeks Receives: Drug: CTA018 Injection |
| CTA018 Injection low to mid dose | Experimental | low to mid dose IV 3 times a week for 4 weeks Receives: Drug: CTA018 Injection |
| CTA018 Injection mid to high dose | Experimental | mid to high dose IV 3 times a week for 4 weeks Receives: Drug: CTA018 Injection |
| CTA018 Injection high dose | Experimental | high dose IV 3 times a week for 4 weeks Receives: Drug: CTA018 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the single and repeat dose pharmacokinetics (PK) of CTA018 Injection
Measured: Day 1 and 12 of each dose level
To investigate the safety of CTA018 Injection
Measured: Throughout the study
Secondary outcomes (2)
To investigate the pharmacodynamic (PD) intact parathyroid hormone (iPTH) response following CTA08 Injection
Measured: Throughout the study
To determine the efficacy of CTA018 Injection to reduce serum iPTH
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 posted28 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2010
- Study completionJun 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT00742716
- Sponsor's protocol ID
- CTA018-CL-2002
- Status last verified
- Jun 2011
- First submitted
- 26 Aug 2008
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Four Week, Dose Escalating Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Study of CTA018 Injection in Subjects With Stage 5 Chronic Kidney Disease With Secondary Hyperparathyroidism on Hemodialysis
- ClinicalTrials.gov ID
- NCT00742716
- Acronym / sponsor ID
- CTA018-CL-2002
- 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 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- OPKO IP Holdings II, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 28 Aug 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 investigate the levels of CTA018 in the body over time (pharmacokinetics, PK) in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis. This study will also investigate the safety and effects of different strengths of CTA018, on parathyroid hormone (PTH) levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CTA018 Injection low dose | Experimental | Drug: CTA018 InjectionLow dose IV 3 times a week for 4 weeks |
| CTA018 Injection low to mid dose | Experimental | Drug: CTA018 Injectionlow to mid dose IV 3 times a week for 4 weeks |
| CTA018 Injection mid to high dose | Experimental | Drug: CTA018 Injectionmid to high dose IV 3 times a week for 4 weeks |
| CTA018 Injection high dose | Experimental | Drug: CTA018 Injectionhigh dose IV 3 times a week for 4 weeks |
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 18 and 35
- On maintenance hemodialysis three times per week
- Serum iPTH value greater than or equal to 300 pg/mL and lower than or equal to 1000 pg/mL
- Adjusted or total serum calcium value greater than or equal to 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 (3 listed)
- On bisphosphonates for at least three months prior to first dose of Study Drug
- Currently 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 |
|---|---|---|
| CTA018 InjectionComparison of different dosages of drug | Drug | CTA018 Injection high dose, CTA018 Injection low dose, CTA018 Injection low to mid dose, CTA018 Injection mid to high dose |
Primary outcome
To assess the single and repeat dose pharmacokinetics (PK) of CTA018 Injection
Time frame: Day 1 and 12 of each dose level
To investigate the safety of CTA018 Injection
Time frame: Throughout the study
2 secondary outcomes
To investigate the pharmacodynamic (PD) intact parathyroid hormone (iPTH) response following CTA08 Injection
Time frame: Throughout the study
To determine the efficacy of CTA018 Injection to reduce serum iPTH
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 6 Nov 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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CTA018 Injection in people with Chronic Kidney Disease and Secondary Hyperparathyroidism, run by OPKO IP Holdings II, Inc. at 12 sites in 2 countries.
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 3 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 6 Nov 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 Canada, 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?
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 single and repeat dose pharmacokinetics (PK) of CTA018 Injection (time frame: Day 1 and 12 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 6 Nov 2014.