A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients - Full Text View

Purpose

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).

Condition	Intervention	Phase
Type 2 Diabetes Mellitus Chronic Kidney Disease	Drug: CTP-499 Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Kidney Problems Kidney Diseases

U.S. FDA Resources

Further study details as provided by Concert Pharmaceuticals:

Primary Outcome Measures:

To assess the change in urinary albumin to creatinine ratio [ Time Frame: Weeks 16, 20, 24 ] [ Designated as safety issue: No ]


Enrollment:	170
Study Start Date:	January 2012
Study Completion Date:	January 2015
Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487109

Show 49 Study Locations

Sponsors and Collaborators

Concert Pharmaceuticals

Investigators


Study Director:	LuAnn Sabounjian	Concert Pharmaceuticals

More Information


Responsible Party:	Concert Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01487109 History of Changes
Other Study ID Numbers:	CP505.2001
Study First Received:	December 5, 2011
Last Updated:	March 12, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by Concert Pharmaceuticals:


Type 2 diabetes chronic kidney disease

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Kidney Diseases Renal Insufficiency, Chronic Diabetic Nephropathies Glucose Metabolism Disorders	Metabolic Diseases Endocrine System Diseases Urologic Diseases Renal Insufficiency Diabetes Complications

ClinicalTrials.gov processed this record on September 23, 2016