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

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Kidney Disease, Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01847092

Run by

Ardelyx

People needed

154

Starts

2013-05-01

Expected to finish

2015-04-01

Last updated by the study team

2020-05-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Creekside Endocrine Associates PC — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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