Status:
COMPLETED
A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
Lead Sponsor:
Ardelyx
Collaborating Sponsors:
AstraZeneca
Conditions:
Chronic Kidney Disease
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT01847092
Start Date
May 1 2013
End Date
April 1 2015
Last Update
May 27 2020
Active Locations (1)
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1
Creekside Endocrine Associates PC
Denver, Colorado, United States, 80209