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
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