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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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).

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus; Chronic Kidney Disease	Drug: CTP-499; Drug: Placebo	Phase 2

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

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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

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. To assess the change in urinary albumin to creatinine ratio [ Time Frame: Weeks 16, 20, 24 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 49 Study Locations

Sponsors and Collaborators

Concert Pharmaceuticals

Investigators

Study Director:	LuAnn Sabounjian	Concert Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Concert Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01487109 History of Changes
Other Study ID Numbers:	CP505.2001
First Posted:	December 7, 2011
Last Update Posted:	March 17, 2015
Last Verified:	July 2014

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