A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | May 2013 |
| End Date: | April 2015 |
An Exploratory Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Design Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD1722 in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
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.
reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.
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
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