CL005_140 CCX140-B in Diabetic Nephropathy

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX140-B in Diabetic Nephropathy

• IRAS ID

  84261

• Contact name

  Daniel Zehnder

• Sponsor organisation

  ChemoCentryx, Inc

• Eudract number

  2011-001267-49

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  CCX140Bis being studied as an orally delivered, disease modifying therapy for patients with diabetic nephropathy(DN). Kidney disease is common among patients with type 2 diabetes mellitus (T2DM) and hypertension. It is characterized by a persistent and usually progressive decline in renal function as measured by glomerular filtration rate (GFR) and/or albuminuria. Given the rise in the incidence of obesity and sedentary lifestyle, the incidence of type 2 diabetes and hypertension has reached epidemic proportions. Treatment of patients with DN includes treatment of the underlying T2DM and hypertension. Angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) are commonly prescribed to control hypertension and slow the progression of DN. Nevertheless, many patients eventually progress to endstage renal disease (ESRD) and require hemodialysis, peritoneal dialysis, or renal transplant. Therefore, an unmet medical need for safe and convenient treatments to retard or reverse the progression of DN persists.CCX140B has potential in the treatment of patients with DN based on published findings indicating that it is a selective antagonist of certain chemokine receptors and ligands which play a part in renal disease, as well as results from ChemoCentryx studies in animal models of DN. Studies conducted in human volunteers have indicated that CCX140B was well tolerated with a pharmacokinetic profile lending it to once daily oral dosing. A subsequent Phase 2 study in 159 subjects with T2DM showed that CCX140B was well tolerated and appeared to be safe when administered at daily oral doses of 5 mg and 10 mg CCX140B. There was evidence of efficacy of the 10 mg CCX140B once daily dosing regimen for improved glycemic control, but not with 5 mg. The rationale for this Phase 2 study is to determine whether CCX140B is safe and well tolerated and shows evidence of renal or diabetic efficacy after oral administration of CCX140B once daily for 84 consecutive days to subjects with DN.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  11/SC/0372

• Date of REC Opinion

  18 Nov 2011

• REC opinion

  Further Information Favourable Opinion