A Study to Evaluate the Soluble Guanylate Cyclase (sGC) Stimulator IW-1973 in Diabetic Nephropathy / Diabetic Kidney Disease as Measured by Albuminuria
NCT ID: NCT03217591
Last Updated: 2022-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
156 participants
INTERVENTIONAL
2017-08-01
2019-08-20
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
TRIPLE
Study Groups
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IW-1973 Low Dose
Administered daily for 12 weeks
IW-1973
Oral Tablet
IW-1973 High Dose
Administered daily for 12 weeks
IW-1973
Oral Tablet
Placebo
Placebo to match experimental drug administered daily for 12 weeks
Placebo
Oral Tablet
Interventions
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IW-1973
Oral Tablet
IW-1973
Oral Tablet
Placebo
Oral Tablet
Eligibility Criteria
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Inclusion Criteria
* Patient has type 2 diabetes diagnosed by a physician or nurse practitioner ≥6 months before the Screening Visit, has been on ≥1 antihyperglycemic medication for ≥12 weeks preceding the Randomization Visit, and has been on a stable regimen (ie, same drug and same dose) of ≥1 antihyperglycemic medication for ≥28 days preceding the Randomization Visit. (Modification of short-acting insulin throughout the Screening Period will not affect eligibility.)
* Patient has been on a stable regimen (ie, same drug and dose) of antihypertensive medications, which must include an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), for ≥28 days preceding the Randomization Visit and is expected to remain on their regimen through the Follow-up Visit.
* Patient has the following:
1. Estimated glomerular filtration rate (eGFR) 30 to 75 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (1) at the Screening and Baseline Visits
2. Urine albumin-to-creatinine ratio (UACR) \>200 mg/g at the Screening and Baseline Visits and \<5000 mg/g at Screening and Baseline Visits
3. Serum albumin \>3.0 g/dL at the Screening and Baseline Visits
4. Hemoglobin A1c (HbA1c) ≤11% at the Screening and Baseline Visits
5. Systolic blood pressure (BP) of 110 to 160 mm Hg at the Screening and Baseline Visits
* Women of childbearing potential must have a negative pregnancy test prior to randomization and must agree to use protocol-specified contraception from the Screening Visit through 60 days after the final dose of study drug.
* Male patients must be surgically sterile by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) or must agree to use protocol-specified contraception from the Screening Visit through 60 days after the final dose of study drug.
Exclusion Criteria
* Patient has a body mass index (BMI) \<20 or \>45 kg/m2 at the Screening Visit.
* Patient has a history of platelet dysfunction, hemophilia, von Willebrand disease, coagulation disorder, other bleeding diathesis, or significant, nontraumatic bleeding episode(s), such as from a gastrointestinal source.
* Patient has hepatic impairment defined as Child-Pugh A, B, C.
* Patient has significant comorbidities (eg, malignancy, advanced liver disease, pulmonary hypertension, pulmonary fibrosis, lung disease requiring supplemental oxygen) or other significant conditions that, in the Investigator's opinion, would limit the patient's ability to complete or participate in this clinical study; has been hospitalized for cardiovascular, renal, or metabolic cause in the 3 months before the Screening Visit; or has a life expectancy of less than 1 year.
* Patient has had prior dialysis, renal transplant, or planned renal transplant.
* Patient has clinically active, symptomatic, or unstable coronary artery or heart disease within the 3 months before the Screening Visit, defined as 1 of the following:
1. Hospitalization for myocardial infarction (MI), unstable angina, or heart failure
2. New-onset angina with positive functional study or coronary angiogram revealing stenosis
3. Coronary revascularization procedure
* Patient has a history of clinically significant hypersensitivity or allergies to any of the inactive ingredients contained in the active or placebo drug products.
* Patient has previously received IW-1973 in a study, or received an investigational drug during the 30 days or 5 half-lives of that investigational drug (whichever is longer) before the Screening Visit, or is planning to receive another investigational drug at any time during the study.
* Patient is taking specific inhibitors of phosphodiesterase 5 (PDE5), nonspecific inhibitors of PDE5 (including dipyridamole and theophylline), any supplements for the treatment of erectile dysfunction, riociguat, or nitrates or nitric oxide (NO) donors in any form. These medications and supplements are prohibited from 7 days before Randomization through the duration of the study.
* Patient is taking strong cytochrome P450 3A (CYP3A) inhibitors (eg, ketoconazole, indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, telithromycin, itraconazole, and nefazodone). These medications are prohibited 14 days before Randomization through the duration of the trial.
25 Years
75 Years
ALL
No
Sponsors
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Cyclerion Therapeutics
INDUSTRY
Akebia Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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John Hanrahan, MD MPH
Role: STUDY_DIRECTOR
Cyclerion Therapeutics, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
California Institute of Renal Research
Chula Vista, California, United States
St. Joseph Heritage Healthcare (St. Jude Hospital DBA)
Fullerton, California, United States
California Institute of Renal Research
La Mesa, California, United States
Torrance Clinical Research Institute, Inc.
Lomita, California, United States
American Institute of Research
Los Angeles, California, United States
Academic Medical Research Institute
Los Angeles, California, United States
California Medical Research Associates, Inc. (CMRA)
Northridge, California, United States
Riverside Nephrology Physicians, Inc.
Riverside, California, United States
California Kidney Specialists
San Dimas, California, United States
North American Research Institute
San Dimas, California, United States
UCLA
Santa Monica, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States
Creekside Endocrine Associates
Denver, Colorado, United States
Christiana Care Health Services
Newark, Delaware, United States
The George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
AGA Clinical Trials
Hialeah, Florida, United States
Leon Medical Research Corp.
Miami, Florida, United States
Elite Clinical Research
Miami, Florida, United States
DL Research Solutions
Miami, Florida, United States
Premier Research Associates, Inc.
Miami, Florida, United States
Sweet Hope Research Speciality, Inc.
Miami Lakes, Florida, United States
IMIC, Inc.
Palmetto Bay, Florida, United States
Atlanta Center for Clinical Research Nephrology
Atlanta, Georgia, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Gwinnett Biomedical Research
Lawrenceville, Georgia, United States
East Coast Institute for Clinical Research
Macon, Georgia, United States
East Coast Institute for Research
Macon, Georgia, United States
Saltzer Medical Group
Nampa, Idaho, United States
Research by Design, LLC
Chicago, Illinois, United States
American Health Network of Indiana
Franklin, Indiana, United States
My Kidney Center
Manhattan, Kansas, United States
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Aa Mrc, Llc
Flint, Michigan, United States
St. Louis Heart & Vascular, P.C.
St Louis, Missouri, United States
NJ Heart, P.A.
Linden, New Jersey, United States
Albany Medical College, Division of Community Endocrinology
Albany, New York, United States
Physicians East Endocrinology
Greenville, North Carolina, United States
Mountain View Clinical Research
Greer, South Carolina, United States
South Carolina Nephrology & Hypertension Center
Orangeburg, South Carolina, United States
University of Tennessee Health Science Center at Memphis University Hospital
Memphis, Tennessee, United States
Pioneer Research Solutions
Beaumont, Texas, United States
Academy of Diabetes, Thyroid and Endocrine, P.A.
El Paso, Texas, United States
The Medical Group of Texas
Fort Worth, Texas, United States
Rockwood Medical Center
Fort Worth, Texas, United States
Endocrine IPS, PLLC
Houston, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
FMC Science, LLC
Lampasas, Texas, United States
Clinical Advancement Center PLLC
San Antonio, Texas, United States
Briggs Clinical Research
San Antonio, Texas, United States
Burke Internal Medicine and Research
Burke, Virginia, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Northside Endocrinology
Spokane, Washington, United States
Countries
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References
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Hanrahan JP, de Boer IH, Bakris GL, Wilson PJ, Wakefield JD, Seferovic JP, Chickering JG, Chien YT, Carlson K, Cressman MD, Currie MG, Milne GT, Profy AT. Effects of the Soluble Guanylate Cyclase Stimulator Praliciguat in Diabetic Kidney Disease: A Randomized Placebo-Controlled Clinical Trial. Clin J Am Soc Nephrol. 2020 Dec 31;16(1):59-69. doi: 10.2215/CJN.08410520. Epub 2020 Dec 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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C1973-203
Identifier Type: -
Identifier Source: org_study_id
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