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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Concert Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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