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

August 6, 2021 updated by: Concert Pharmaceuticals

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85282
        • Agave Clinical Research
    • Arkansas
      • Harrisburg, Arkansas, United States, 72432
        • Harrisburg Family Medical Center
      • Little Rock, Arkansas, United States, 72204
        • Arkansas Primary Care Clinic
    • California
      • Burbank, California, United States, 91505
        • Providence Clinical Research
      • Chula Vista, California, United States, 91910
        • California Institute of Renal Research
      • Garden Grove, California, United States, 92844
        • SC Clinical Research
      • Lakewood, California, United States, 90712
        • Premiere Clinical Research
      • Long Beach, California, United States, 90806
        • Long Beach Center For Clinical Research
      • Long Beach, California, United States, 90807
        • Premiere Clinical Research
      • Los Angeles, California, United States, 90024
        • UCLA Kidney Transplant Research
      • Los Angeles, California, United States, 90095
        • David Geffen School of Medicine Division of Nephrology
      • Palm Springs, California, United States, 92262
        • Desert Oasis Healthcare Medical Group
      • Riverside, California, United States, 92505
        • Apex Research of Riverside
      • Sacramento, California, United States, 95816
        • River City Clinical Research
      • San Diego, California, United States, 92123
        • California Institute of Renal Research
      • Santa Barbara, California, United States, 93110
        • Samsun Clinic
      • Tustin, California, United States, 92780
        • Orange County Research Center
      • West Hills, California, United States, 91307
        • Infosphere Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80209
        • Creekside Endocrine Associates
    • Florida
      • Hialeah, Florida, United States, 33012
        • Palm Spring Research Institute
      • Miami, Florida, United States, 33015
        • San Marcus Research Clinic, Inc.
      • Miami, Florida, United States, 33136
        • Advanced Pharma CR
      • Ormond Beach, Florida, United States, 32174
        • Ormond Medical Arts Pharmaceutical Research
      • Winter Haven, Florida, United States, 33880
        • Clincal Research of Central Florida
    • Georgia
      • Blue Ridge, Georgia, United States, 30513
        • River Birch Research Alliance
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60616
        • Apex Medical Research
    • Indiana
      • Avon, Indiana, United States, 46123
        • American Health Network of IN
      • Greenfield, Indiana, United States, 46140
        • American Healthcare Network of Indiana
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • MedStar Health Research Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02215
        • Harvard Medical School Beth Israel Deaconess Medical Center
    • Michigan
      • Flint, Michigan, United States, 48504
        • Apex Medical Research MI
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Clinical Research Consultants (MO)
    • New York
      • New York, New York, United States, 10021
        • The Rogosin Institute
      • Rosedale, New York, United States, 11422
        • Clinical Research Development Associates (NY)
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina School of Medicine
    • Ohio
      • Canton, Ohio, United States, 44718
        • Clinical Research Limited
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Lynn Institute of Norman
    • South Carolina
      • Aiken, South Carolina, United States, 29801
        • C.S.R.A. Renal Services
      • Charleston, South Carolina, United States, 29412
        • Pharmacorp Clinical Trials
      • Greer, South Carolina, United States, 29651
        • Mountain View Clinical Research
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77054
        • Millenium Clinical Research
      • Houston, Texas, United States, 77054
        • Research Across America
      • San Antonio, Texas, United States, 78215
        • Renal Associates
      • San Antonio, Texas, United States, 78228
        • Panacea Clinical Research
      • San Antonio, Texas, United States, 78229
        • Cetero
    • Washington
      • Tacoma, Washington, United States, 98405
        • Multicare Research Institute (WA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the change in urinary albumin to creatinine ratio
Time Frame: Weeks 16, 20, 24
Weeks 16, 20, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Concert Pharmaceuticals

Investigators

  • Study Director: LuAnn Sabounjian, Concert Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (Estimate)

December 7, 2011

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 6, 2021

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP505.2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe