A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
NCT ID: NCT01847092
Last Updated: 2020-05-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
154 participants
INTERVENTIONAL
2013-05-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
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
AZD1722
Placebo
Placebo capsule BID PO for 12 Weeks
Placebo
Placebo for AZD1722
Interventions
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AZD1722
Placebo
Placebo for AZD1722
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Ardelyx
INDUSTRY
Responsible Party
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Locations
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Creekside Endocrine Associates PC
Denver, Colorado, United States
Countries
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Other Identifiers
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D5610C00001
Identifier Type: -
Identifier Source: org_study_id
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