A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
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
1 other identifier
interventional
154
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 2, 2013
CompletedFirst Posted
Study publicly available on registry
May 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
May 27, 2020
CompletedMay 27, 2020
May 1, 2020
1.8 years
May 2, 2013
May 9, 2020
May 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint
12 weeks
Study Arms (2)
AZD1722
ACTIVE COMPARATORAZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks
Placebo
PLACEBO COMPARATORPlacebo capsule BID PO for 12 Weeks
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ardelyxlead
- AstraZenecacollaborator
Study Sites (1)
Creekside Endocrine Associates PC
Denver, Colorado, 80209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Development Officer
- Organization
- Ardelyx
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2013
First Posted
May 6, 2013
Study Start
May 1, 2013
Primary Completion
March 1, 2015
Study Completion
April 1, 2015
Last Updated
May 27, 2020
Results First Posted
May 27, 2020
Record last verified: 2020-05