A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01487109 |
Recruitment Status :
Completed
First Posted : December 7, 2011
Last Update Posted : August 16, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus Chronic Kidney Disease | Drug: CTP-499 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 170 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
matching placebo tablets
|
Drug: Placebo
Matching placebo tablet |
Active Comparator: CTP-499
600 mg tablet
|
Drug: CTP-499
600 mg tablet twice daily |
- To assess the change in urinary albumin to creatinine ratio [ Time Frame: Weeks 16, 20, 24 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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%
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487109

Study Director: | LuAnn Sabounjian | Concert Pharmaceuticals |
Responsible Party: | Concert Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01487109 |
Other Study ID Numbers: |
CP505.2001 |
First Posted: | December 7, 2011 Key Record Dates |
Last Update Posted: | August 16, 2021 |
Last Verified: | July 2014 |
Type 2 diabetes chronic kidney disease |
Kidney Diseases Renal Insufficiency, Chronic Diabetic Nephropathies Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Urologic Diseases Renal Insufficiency Diabetes Complications |