Study to evaluate the effect of CCX140-B on albuminuria in subjects with type 2 diabetes mellitus
| ISRCTN | ISRCTN81307356 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81307356 |
| ClinicalTrials.gov number | NCT01440257 |
| Secondary identifying numbers | CL007_140 |
- Submission date
- 27/10/2011
- Registration date
- 02/12/2011
- Last edited
- 18/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Centre for Human Drug Research
Zernikedreef 10
Leiden
2333 CL
Netherlands
| kb@chdr.nl |
Study information
| Study design | Randomized double-blind placebo-controlled single-center phase 2a study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| 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 |
| Study objectives | 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(s) | Leiden University Medical Center Medical Ethics Committee, Leiden, Netherlands approved on 29 August 2011, ref: CHDR 1112 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2011 |
| Completion date | 30/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | Approximately 20 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/09/2011 |
| Date of final enrolment | 30/06/2012 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
2333 CL
Netherlands
Sponsor information
Industry
850 Maude Avenue
Mountain View, CA
94043
United States of America
| Website | http://www.ChemoCentryx.com |
|---|---|
"ROR" |
https://ror.org/04gp12571 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2015 | 18/01/2019 | Yes | No |
Editorial Notes
18/01/2019: Publication reference added
