Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/11/2011
Date assigned
12/01/2012
Last edited
27/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients with type 2 diabetes mellitus may eventually develop kidney damage called diabetic nephropathy. Patients with this disease are usually treated with diabetic medication as well as drugs to lower their blood pressure and reduce the deterioration of their kidney function. Despite these treatments, many patients eventually progress to severe kidney disease and require dialysis or kidney transplant. Therefore, there is an unmet medical need for safe and convenient treatments to slow down or reverse the progression of diabetic nephropathy. The aim of this study is to test the safety and effectiveness of a new drug, CCX140-B, in patients with diabetic nephropathy.

Who can participate?
Males and female patients, aged 18-75, who have been diagnosed with diabetic nephropathy.

What does the study involve?
Patients will be randomly allocated to take either capsules of CCX140-B, capsules without a drug (placebo), or a mixture of both capsules. The capsules are to be taken by mouth once daily for a period of 84 days.

What are the possible benefits and risks of participating?
Previous studies have shown evidence that CCX140-B may have an effect on blood glucose and may cause an improvement in protein excretion in the urine, which is an indicator of diabetic nephropathy. CCX140-B appeared to be well tolerated in previous studies, but all new drugs have the potential for unanticipated serious or life-threatening adverse events.

Where is the study run from?
The countries participating in this study are Belgium, Czech Republic, Germany, Hungary, Poland, and the UK.

When is the study starting and how long is it expected to run for?
From November 2011 to August 2012.

Who is funding the study?
ChemoCentryx, Inc. (USA).

Who is the main contact?
Daniel Johnson
djohnson@chemocentryx.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Daniel Johnson

ORCID ID

Contact details

850 Maude Avenue
Mountain View
CA
94043
United States of America
+1 (0)650 210 2900
djohnson@chemocentryx.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01447147

Protocol/serial number

CL005_140

Study information

Scientific title

A randomized, double-blind, placebo-controlled, phase 2 study to evaluate the safety and efficacy of CCX140-B in diabetic nephropathy

Acronym

Study hypothesis

The rationale for this phase 2 study is to determine whether CCX140-B is safe and well tolerated and shows evidence of renal or diabetic efficacy after oral administration of CCX140-B once daily for 84 consecutive days to subjects with diabetic nephropathy.

Because CCX140-B blocks the monocyte/macrophage migration from blood to tissues that occurs only during inflammation, it is anticipated that administration of CCX140-B will provide selective therapeutic benefit without compromising general immune surveillance.

Ethics approval

University Hospital Gent Commission on Medical Ethics, Gent, Belgium, 28/09/2011, ref: 2011/502. All other centres will seek ethics approval before recruitment of the first participant.

Study design

Randomized double-blind placebo-controlled multi-center phase 2 study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diabetic nephropathy

Intervention

Group A: Four placebo capsules once daily for 84 days. Following the 84-day dosing period, there will be a 28-day safety follow-up period.

Group B: Two 2.5 mg CCX140-B capsules and two placebo capsules once daily for 84 days. Following the 84-day dosing period, there will be a 28-day safety follow-up period.

Group C: Four 2.5 mg CCX140-B capsules once daily for 84 days

Following the 84-day dosing period, there will be a 28-day safety follow-up period.

Intervention type

Drug

Phase

Phase II

Drug names

CCX140-B

Primary outcome measures

To evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy

Secondary outcome measures

Change from baseline in first morning urinary albumin:creatine ration (ACR)

Overall trial start date

30/11/2011

Overall trial end date

31/08/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (as per American Diabetes Association [ADA] criteria)
2. 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 200 to 3000 mg/g creatinine, inclusive)
3. Estimated glomerular filtration rate (eGFR) based on serum creatinine determined by Modification of Diet in Renal Disease [MDRD] equation of greater than or equal to 25 mL/min/1.73 m(2)
4. 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
5. Hemoglobin A1c (HbA1c) > 6.0% but not > 10.0% and fasting plasma glucose less than 270 mg/dL at screening

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Approximately 135

Participant exclusion criteria

1. Type 1 diabetes mellitus or history of diabetic ketoacidosis
2. Previous renal transplant or known non-diabetic renal disease, except related to hypertension
3. Undergone renal dialysis at any time in the past
4. Received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening
5. Use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening
6. Received chronic (more than 7 days continuously) non-steroidal anti-inflammatory drug (NSAID) treatment within 2 weeks of screening
7. Cardiac failure (class III or IV), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening
8. 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)

Recruitment start date

30/11/2011

Recruitment end date

31/08/2012

Locations

Countries of recruitment

Belgium, Czech Republic, Germany, Hungary, Poland, United Kingdom

Trial participating centre

850 Maude Avenue
Mountain View, CA
94043
United States of America

Sponsor information

Organisation

ChemoCentryx, Inc. (USA)

Sponsor details

850 Maude Avenue
Mountain View
CA
94043
United States of America

Sponsor type

Industry

Website

http://www.chemocentryx.com

Funders

Funder type

Industry

Funder name

ChemoCentryx, Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes