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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847092
• Other study ID #: D5610C00001
• Status: Completed
• Phase: Phase 2
• Start date: May 2013
• Est. completion date: April 2015

Study information

• Verified date: May 2020
• Source: Ardelyx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Albuminuria
• Chronic Kidney Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes Mellitus

Intervention

Drug:
• AZD1722

• Placebo
Placebo for AZD1722

Locations

Country	Name	City	State
United States	Creekside Endocrine Associates PC	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Ardelyx	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Urine Albumin to Creatinine Ratio (UACR)	The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment	Week 12
Secondary	Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint		12 weeks