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

Primary Purpose

Chronic Kidney Disease, Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AZD1722
Placebo
Sponsored by
Ardelyx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring albuminuria

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Creekside Endocrine Associates PC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AZD1722

Placebo

Arm Description

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

Placebo capsule BID PO for 12 Weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 2, 2013
Last Updated
May 9, 2020
Sponsor
Ardelyx
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01847092
Brief Title
A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ardelyx
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Keywords
albuminuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZD1722
Arm Type
Active Comparator
Arm Description
AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule BID PO for 12 Weeks
Intervention Type
Drug
Intervention Name(s)
AZD1722
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for AZD1722
Primary Outcome Measure Information:
Title
Changes in Urine Albumin to Creatinine Ratio (UACR)
Description
The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Creekside Endocrine Associates PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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