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

NCT ID: NCT01847092

Last Updated: 2020-05-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-04-30

Brief Summary

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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

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Conditions

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Chronic Kidney Disease Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AZD1722

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

Group Type ACTIVE_COMPARATOR

AZD1722

Intervention Type DRUG

Placebo

Placebo capsule BID PO for 12 Weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for AZD1722

Interventions

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AZD1722

Intervention Type DRUG

Placebo

Placebo for AZD1722

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Ardelyx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Creekside Endocrine Associates PC

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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D5610C00001

Identifier Type: -

Identifier Source: org_study_id

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