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
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