Type 2 Diabetes MellitusPhase 2NCT01487109
A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients
A Phase 2 study testing CTP-499 in people with Type 2 Diabetes Mellitus and Chronic Kidney Disease, run by Concert Pharmaceuticals at 49 sites in United States.
Trial summary
This study is being conducted to evaluate the safety and efficacy of treatment with CTP-499 for 24 weeks in patients with chronic kidney disease, Type 2 diabetic nephropathy and who are currently receiving treatment with an angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin II receptor blocker (ARB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Chronic Kidney Disease
- What is being tested?
- CTP-499
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 49 sitesUnited States
- Study dates
- Jan 2012to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 years or older
- Patient diagnosed with Type 2 diabetes mellitus and chronic kidney disease
- On a stable regimen of ACE inhibitors and/or ARB drugs for a minimum of 4 weeks
- Not expected to start dialysis for one year
- Patient has blood pressure less than or equal to 145/90 mm Hg
- Patient has UACR greater than or equal to 200 mg/g if male and 300 mg/g if female but not more than 5000 mg/g
- Patient has glycosylated hemoglobin A1c less than or equal to 10.5%
Who cannot join
- Patient has concurrent condition such as uncontrolled inflammatory disease, acute infection or other unstable illnesses
- Patient has a history of allergy or sensitivity to pentoxifylline or methylxanthines
- Patient has acute, active and/or unstable renal impairment or has been hospitalized for acute renal failure within the previous year
- Patient has active malignancy or history of neoplastic disease
- Patient has a QTc interval greater than 450 milliseconds
- Patient has ALT or AST greater than 3 times the upper limit of normal or a potassium greater than or equal to 5.5mEq/L at screening
- Patient is breast feeding or pregnant
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
United States49 sites
C.S.R.A. Renal Services
Aiken, South Carolina, 29801
American Health Network of IN
Avon, Indiana, 46123
River Birch Research Alliance
Blue Ridge, Georgia, 30513
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Harvard Medical School Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Providence Clinical Research
Burbank, California, 91505
Clinical Research Limited
Canton, Ohio, 44718
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599
Pharmacorp Clinical Trials
Charleston, South Carolina, 29412
Apex Medical Research
Chicago, Illinois, 60616
University of Chicago Medical Center
Chicago, Illinois, 60637
California Institute of Renal Research
Chula Vista, California, 91910
Creekside Endocrine Associates
Denver, Colorado, 80209
Apex Medical Research MI
Flint, Michigan, 48504
SC Clinical Research
Garden Grove, California, 92844
American Healthcare Network of Indiana
Greenfield, Indiana, 46140
Mountain View Clinical Research
Greer, South Carolina, 29651
Harrisburg Family Medical Center
Harrisburg, Arkansas, 72432
Palm Spring Research Institute
Hialeah, Florida, 33012
Millenium Clinical Research
Houston, Texas, 77054
Research Across America
Houston, Texas, 77054
Medstar Health Research Institute
Hyattsville, Maryland, 20782
Clinical Research Consultants (MO)
Kansas City, Missouri, 64111
Premiere Clinical Research
Lakewood, California, 90712
Arkansas Primary Care Clinic
Little Rock, Arkansas, 72204
Long Beach Center for Clinical Research
Long Beach, California, 90806
Premiere Clinical Research
Long Beach, California, 90807
UCLA Kidney Transplant Research
Los Angeles, California, 90024
David Geffen School of Medicine Division of Nephrology
Los Angeles, California, 90095
San Marcus Research Clinic, Inc.
Miami, Florida, 33015
Advanced Pharma CR
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
The Rogosin Institute
New York, New York, 10021
Lynn Institute of Norman
Norman, Oklahoma, 73069
Ormond Medical Arts Pharmaceutical Research
Ormond Beach, Florida, 32174
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262
Apex Research of Riverside
Riverside, California, 92505
Clinical Research Development Associates (NY)
Rosedale, New York, 11422
River City Clinical Research
Sacramento, California, 95816
Renal Associates
San Antonio, Texas, 78215
Panacea Clinical Research
San Antonio, Texas, 78228
Cetero
San Antonio, Texas, 78229
California Institute of Renal Research
San Diego, California, 92123
Samsun Clinic
Santa Barbara, California, 93110
Multicare Research Institute (WA)
Tacoma, Washington, 98405
Agave Clinical Research
Tempe, Arizona, 85282
Orange County Research Center
Tustin, California, 92780
Infosphere Clinical Research
West Hills, California, 91307
Clincal Research of Central Florida
Winter Haven, Florida, 33880
About this study
Official title: A Phase 2, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients Currently Treated With ACEI and/or ARB Therapy
This study is being conducted to evaluate the safety and efficacy of treatment with CTP-499 for 24 weeks in patients with chronic kidney disease, Type 2 diabetic nephropathy and who are currently receiving treatment with an angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin II receptor blocker (ARB).
Read the detailed description
There are two parts to this study, each part includes double-blind treatment with either CTP-499 or placebo. Part 1 will evaluate the safety and efficacy of treatment with CTP-499 twice daily for 24 weeks. Part 2 will evaluate the effects of longer term dosing for an additional 24 weeks. Following Part 2, patients will be allowed to participate in an Open Label extension with CTP-499 for a period of an additional 48 weeks.
- Conditions
- Type 2 Diabetes Mellitus, Chronic Kidney Disease
- Being tested
- CTP-499, Placebo
- Keywords
- Type 2 diabetes, chronic kidney disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTP-499Drug
600 mg tablet twice daily
PlaceboDrug
Matching placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | matching placebo tablets Receives: Drug: Placebo |
| CTP-499 | Active comparator | 600 mg tablet Receives: Drug: CTP-499 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the change in urinary albumin to creatinine ratio
Measured: Weeks 16, 20, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concert Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- LuAnn Sabounjian, Study director, Concert Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487109
- Sponsor's protocol ID
- CP505.2001
- Status last verified
- Jul 2014
- First submitted
- 5 Dec 2011
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients Currently Treated With ACEI and/or ARB Therapy
- ClinicalTrials.gov ID
- NCT01487109
- Acronym / sponsor ID
- CP505.2001
- Conditions
- Type 2 Diabetes Mellitus, Chronic Kidney Disease
- Keywords
- Type 2 diabetes, chronic kidney disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Concert PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 7 Dec 2011 (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 is being conducted to evaluate the safety and efficacy of treatment with CTP-499 for 24 weeks in patients with chronic kidney disease, Type 2 diabetic nephropathy and who are currently receiving treatment with an angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin II receptor blocker (ARB).
Detailed description
There are two parts to this study, each part includes double-blind treatment with either CTP-499 or placebo. Part 1 will evaluate the safety and efficacy of treatment with CTP-499 twice daily for 24 weeks. Part 2 will evaluate the effects of longer term dosing for an additional 24 weeks. Following Part 2, patients will be allowed to participate in an Open Label extension with CTP-499 for a period of an additional 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebomatching placebo tablets |
| CTP-499 | Active comparator | Drug: CTP-499600 mg tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female 18 years or older
- Patient diagnosed with Type 2 diabetes mellitus and chronic kidney disease
- On a stable regimen of ACE inhibitors and/or ARB drugs for a minimum of 4 weeks
- Not expected to start dialysis for one year
- Patient has blood pressure less than or equal to 145/90 mm Hg
Key exclusion criteria (7 listed)
- Patient has concurrent condition such as uncontrolled inflammatory disease, acute infection or other unstable illnesses
- Patient has a history of allergy or sensitivity to pentoxifylline or methylxanthines
- Patient has acute, active and/or unstable renal impairment or has been hospitalized for acute renal failure within the previous year
- Patient has active malignancy or history of neoplastic disease
- Patient has a QTc interval greater than 450 milliseconds
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 |
|---|---|---|
| CTP-499600 mg tablet twice daily | Drug | CTP-499 |
| PlaceboMatching placebo tablet | Drug | Placebo |
Primary outcome
To assess the change in urinary albumin to creatinine ratio
Time frame: Weeks 16, 20, 24
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 16 Aug 2021.
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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.
LuAnn Sabounjian study director
Concert Pharmaceuticals
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CTP-499 in people with Type 2 Diabetes Mellitus and Chronic Kidney Disease, run by Concert Pharmaceuticals at 49 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 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 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. 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 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 change in urinary albumin to creatinine ratio (time frame: Weeks 16, 20, 24). 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 16 Aug 2021.