A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy

August 24, 2023 updated by: ChemoCentryx

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX140-B in Diabetic Nephropathy

The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B in subjects with diabetic nephropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy based on subject incidence of adverse events.

The secondary objectives of this study include evaluation of the effect of CCX140-B on several measures of effectiveness commonly used in the evaluation of diabetes and renal medications.

Study Type

Interventional

Enrollment (Actual)

332

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

  • Belgium
      • Antwerp, Belgium
      • Brussels, Belgium
      • Edegem, Belgium
      • Ghent, Belgium
      • Leuven, Belgium
      • Liege, Belgium
      • Roeselare, Belgium
  • Czechia
      • Beroun, Czechia
      • Brno, Czechia
      • Hlucin, Czechia
      • NZdar Nad Sazavou, Czechia
      • Neratovice, Czechia
      • Novy Jicin, Czechia
      • Pardubice, Czechia
      • Prague, Czechia
      • Prelouc, Czechia
      • Rakovnik, Czechia
      • Slany, Czechia
      • Trebic, Czechia
      • Uhersky Brod, Czechia
      • Unicov, Czechia
  • Germany
      • Berlin, Germany
      • Bosenheim, Germany
      • Deggingen, Germany
      • Dresden, Germany
      • Erlangen, Germany
      • Hannover, Germany
      • Heidelberg, Germany
      • Heilbronn, Germany
      • Hoyerswerda, Germany
      • Koeln, Germany
      • Munich, Germany
      • Neuwied, Germany
      • Nuernberg, Germany
      • Pirna, Germany
      • Potsdam, Germany
      • Saarlouis, Germany
      • Speyer, Germany
      • Wiesbaden, Germany
  • Hungary
      • Baja, Hungary
      • Balatonfuered, Hungary
      • Bekescsaba, Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Eger, Hungary
      • Gyula, Hungary
      • Hatvan, Hungary
      • Kaposvar, Hungary
      • Kisvarda, Hungary
      • Satoraljaujhely, Hungary
      • Szekszard, Tolna, Hungary
      • Szikszo, Hungary
  • Poland
      • Bialystok, Poland
      • Ciechanow, Poland
      • Gdansk, Poland
      • Grodzisk Mazowiecki, Poland
      • Krakow, Poland
      • Poznan, Poland
      • Radom, Poland
      • Rzeszow, Poland
      • Szczecin, Poland
      • Warsaw, Poland
      • Wroclaw, Poland
  • United Kingdom
      • Bath, United Kingdom
      • Belfast, United Kingdom
      • Birmingham, United Kingdom
      • Bristol, United Kingdom
      • Chester, United Kingdom
      • Coventry, United Kingdom
      • Doncaster, United Kingdom
      • Edmonton, United Kingdom
      • Liverpool, United Kingdom
      • Livingston, United Kingdom
      • London, United Kingdom
      • Londonderry, United Kingdom
      • Manchester, United Kingdom
      • Middlesbrough, United Kingdom
      • Norfolk, United Kingdom
      • Preston, United Kingdom
      • Salford, United Kingdom
      • Sheffield, United Kingdom
      • Swansea, United Kingdom
      • Welwyn Garden City, United Kingdom

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association [ADA] criteria)
  • Residual albuminuria despite stable treatment with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) for at least 8 weeks prior to screening (Albumin:creatinine ratio [ACR] of 100 to 3000 mg/g creatinine, inclusive)
  • Estimated glomerular filtration rate based on serum creatinine (eGFR, determined by Modification of Diet in Renal Disease [MDRD] equation) of ≥ 25 mL/min/1.73 m(2)
  • Must be on a stable dose of an ACE inhibitor or ARB for at least 8 weeks prior to screening, but subjects must not be on both an ACE inhibitor and an ARB
  • Hemoglobin A1c (HbA1c) > 6.0% but not > 10.0% and fasting plasma glucose less than 270 mg/dL at screening

Key Exclusion Criteria:

  • Type 1 diabetes mellitus or history of diabetic ketoacidosis
  • Previous renal transplant or known non-diabetic renal disease, except related to hypertension
  • Undergone renal dialysis at any time in the past
  • Received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening
  • Use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening
  • Received chronic (more than 7 days continuously) non-steroidal anti-inflammatory drug (NSAID) treatment within 2 weeks of screening
  • Cardiac failure (class III or IV), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening
  • Poorly-controlled blood pressure (systolic blood pressure >155 or diastolic blood pressure >95, with blood pressure measured in the seated position after at least 5 minutes of rest)

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo (Group A)
Drug: Placebo
Placebo capsules once daily
Experimental: CCX140-B (Group B)
Drug: CCX140-B
CCX140-B capsules once daily (Group C)
Drug: CCX140-B
CCX140-B capsules once daily (Group B)
Experimental: CCX140-B (Group C)
Drug: CCX140-B
CCX140-B capsules once daily (Group C)
Drug: CCX140-B
CCX140-B capsules once daily (Group B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject incidence of adverse events
Time Frame: Up to 365 days
The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy.
Up to 365 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in first morning urinary albumin:creatinine ratio (ACR)
Time Frame: Up to 365 days
Up to 365 days

Collaborators and Investigators

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

Sponsor

ChemoCentryx

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 4, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimated)

October 6, 2011

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL005_140

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 Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe