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

Phase 2

Completed

• Conditions: Chronic Kidney Disease; Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: AZD1722

• Registration Number: NCT01847092
• Lead Sponsor: Ardelyx

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-06
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Status Verified: 2020-05
• Results First Submitted: 2020-05-09
• Results First Submitted QC: 2020-05-09
• Last Update Submitted: 2020-05-09
• Results First Posted: 2020-05-27
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsule BID PO for 12 Weeks
AZD1722	AZD1722	AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks

Primary Outcome Measures

Name	Time	Method
Changes in Urine Albumin to Creatinine Ratio (UACR)	Week 12	The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint	12 weeks

Trial Locations

Locations (1)

Creekside Endocrine Associates PC; 🇺🇸 Denver, Colorado, United States