A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ardelyx
• Collaborator: AstraZeneca

Criteria

Inclusion Criteria:

• Males or females aged 18 to 80 years, inclusive.

• Body mass index between 18 and 45 kg/m2, inclusive.

• Type 2 diabetes mellitus and receiving ≥1 glucose lowering medication for at least 3 months prior to randomization

• Stage 3 CKD

• MSSBP ≥130 mmHg

• Urinary albumin: mean UACR ≥ 200 mg/g

Exclusion Criteria:

• Urinary albumin: UACR > 3500 mg/g

• History of a renal transplant

• MSSBP >180 mmHg or a MSDBP of >120 mmHg on two occasions during screening or run-in periods

• History of inflammatory bowel disease or diarrhea predominant irritable bowel syndrome