Study of Olmesartan Medoxomil (CS-866) in Patients With Chronic Glomerulonephritis or Diabetic Nephropathy

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Diabetic Nephropathy; Chronic Glomerulonephritis

Treatments: Drug: olmesartan medoxomil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00914524

CS0866-C-J201

Details and patient eligibility

About

The treatment period was 16 weeks, the initial dose, 5 mg, was unforcedly titrated to 10 mg, 20 mg and 40 mg after confirming tolerance at weeks 4, 8 and 12. The primary endpoint for efficacy was the change in the urinary protein/creatinine ratio from baseline to the end of treatment. The secondary endpoint was creatinine clearance (Ccr).

Enrollment: 49 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• urinary protein/creatinine ratio in the 0.50 g/g to 3.50 g/g creatinine range
• normal sitting blood pressure values: systolic blood pressure of 100 mmHg or above but below 140 mmHg; diastolic blood pressure of 50 mmHg or above but less than 90 mmHg

Exclusion criteria

• treatment with corticosteroids or immunosuppressants
• treatment with antihypertensives (other than ARBs and ACE inhibitors)
• serum potassium level of 5.5 mEq/l or above
• serum creatinine level of 2.0 mg/dl or above

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Treatment

Experimental group

Description:

16 weeks of treatment starting with 5 mg of olmesartan medoxomil. If tolerated, the dose was increased to the next higher dose at weeks 4, 8, and 12.

Treatment:

Drug: olmesartan medoxomil