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

Ardelyx

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease; Type 2 Diabetes Mellitus

Treatments: Drug: AZD1722; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01847092

D5610C00001

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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154 participants in 2 patient groups, including a placebo group

AZD1722

Active Comparator group

Description:

AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks

Treatment:

Drug: AZD1722

Placebo

Placebo Comparator group

Description:

Placebo capsule BID PO for 12 Weeks

Treatment:

Drug: Placebo