Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/10/2011
Date assigned
02/12/2011
Last edited
05/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
People with type 2 diabetes mellitus may develop kidney failure after a period of time. Albuminuria is the presence of a type of protein (called albumin) in the urine, and may also be a sign of kidney failure. Although the cause of this type of kidney injury is not fully known, the immune system appears to contribute. CCX140-B is a new drug which may prevent certain immune system cells from damaging the kidneys.
This study will test whether albumin levels can be reduced in people with type 2 diabetes mellitus. In this study CCX140-B is an additional therapy; it does not replace the standard treatment for kidney failure or type 2 diabetes mellitus.

Who can participate?
Men and women ages 18 to 75 years with diagnosed type 2 diabetes mellitus, with evidence of some kidney injury.

What does the study involve?
Half of the participants will receive 4 capsules of CCX140-B every day for 12 weeks, and the other half will receive 4 capsules without any drug every day for 12 weeks.

What are the possible benefits and risks of participating?
CCX140-B may be able to prevent kidney damage in future patients who have type 2 diabetes mellitus. Side effects of CCX140-B were mild in nature, however all investigational new drugs have the potential for unanticipated serious or life-threatening side effects.

Where is the study run from?
Centre for Human Drug Research, the Netherlands

When is the study starting and how long is it expected to run for?
Enrolment began in September 2011 and the study finished in June 2012.

Who is funding the study?
ChemoCentryx, USA

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Koos Burggraaf

ORCID ID

Contact details

Centre for Human Drug Research
Zernikedreef 10
Leiden
2333 CL
Netherlands
kb@chdr.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01440257

Protocol/serial number

CL007_140

Study information

Scientific title

A randomized, double-blind, placebo-controlled phase 2 study to evaluate the effect of CCX140-B on albuminuria in subjects with type 2 diabetes mellitus

Acronym

Study hypothesis

The rationale for this study is to investigate whether CCX140-B treatment of subjects with type 2 diabetes mellitus (T2DM) and albuminuria can reduce albuminuria. 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

Leiden University Medical Center Medical Ethics Committee, Leiden, Netherlands approved on 29 August 2011, ref: CHDR 1112

Study design

Randomized double-blind placebo-controlled single-center phase 2a 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

Type 2 Diabetes Mellitus with albuminuria

Intervention

Treatment: Four CCX140-B 2.5 mg capsules once daily for 84 days
Control: Four Placebo capsules once daily for 84 days
Following the 84-day dosing period, there will be a 28-day follow-up period

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

1. Change from baseline in 24-hour urinary albumin excretion over 84 days
2. Subject incidence of adverse events over 84 days

Secondary outcome measures

Change in baseline of hemoglobin A1c over 84 days

Overall trial start date

01/09/2011

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female, aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association [ADA] criteria)
2. Albumin:creatinine ratio (ACR) of 200 to 3000 mg/g creatinine, inclusive, based on two values obtained from two first morning urine samples taken on two separate days during the screening period
3. Estimated glomerular filtration rate based on serum creatinine (eGFR), determined by Modification of Diet in Renal Disease [MDRD] equation of greater than or equal to 25 mL/min/1.73 m2
4. Must be on a stable dose of an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) for at least 8 weeks prior to screening
5. Fasting plasma glucose less than 270 mg/dL at screening

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Approximately 20

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. Has 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 (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

01/09/2011

Recruitment end date

30/06/2012

Locations

Countries of recruitment

Netherlands

Trial participating centre

Centre for Human Drug Research
Leiden
2333 CL
Netherlands

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