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A Study to Evaluate the Soluble Guanylate Cyclase (sGC) Stimulator IW-1973 in Diabetic Nephropathy / Diabetic Kidney Disease as Measured by Albuminuria

Sponsor
Cyclerion Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT03217591
Collaborator
(none)
156
Enrollment
54
Locations
3
Arms
24.6
Actual Duration (Months)
2.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the safety and efficacy of IW-1973 in patients with type 2 diabetes mellitus with albuminuria who are on a stable regimen of renin-angiotensin system inhibitors.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
156 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Phase 2, randomized, double-blind, placebo-controlled, parallel-group studyPhase 2, randomized, double-blind, placebo-controlled, parallel-group study
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of IW-1973 in Patients With Type 2 Diabetes With Albuminuria Treated With Renin-Angiotensin System Inhibitors
Actual Study Start Date :
Aug 1, 2017
Actual Primary Completion Date :
Aug 20, 2019
Actual Study Completion Date :
Aug 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: IW-1973 Low Dose

Administered daily for 12 weeks

Drug: IW-1973
Oral Tablet
Experimental: IW-1973 High Dose

Administered daily for 12 weeks

Drug: IW-1973
Oral Tablet
Placebo Comparator: Placebo

Placebo to match experimental drug administered daily for 12 weeks

Drug: Placebo
Oral Tablet

Outcome Measures

Primary Outcome Measures

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs. [From Randomization through Follow-Up Visit (Day 115 ± 3 days)]

  2. Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) at Weeks 8 and 12. [(Baseline, Week 8, Week 12)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:

  • Patient is an ambulatory male or female from 25 to 75 years old at the Screening Visit.

  • 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.

  • Other inclusion criteria per protocol.

Key Exclusion Criteria:

  • Patient has a history of secondary hypertension (ie, renal artery stenosis, primary aldosteronism, or pheochromocytoma).

  • 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.

  • Other exclusion criteria per protocol.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294
2 California Institute of Renal Research Chula Vista California United States 91910
3 St. Joseph Heritage Healthcare (St. Jude Hospital DBA) Fullerton California United States 92835
4 California Institute of Renal Research La Mesa California United States 91942
5 Torrance Clinical Research Institute, Inc. Lomita California United States 90717
6 American Institute of Research Los Angeles California United States 90017
7 Academic Medical Research Institute Los Angeles California United States 90022
8 California Medical Research Associates, Inc. (CMRA) Northridge California United States 91324
9 Riverside Nephrology Physicians, Inc. Riverside California United States 92503
10 California Kidney Specialists San Dimas California United States 91773
11 North American Research Institute San Dimas California United States 91773
12 UCLA Santa Monica California United States 90025
13 Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Torrance California United States 90502
14 Creekside Endocrine Associates Denver Colorado United States 80209
15 Christiana Care Health Services Newark Delaware United States 19713
16 The George Washington University Medical Faculty Associates Washington District of Columbia United States 20037
17 AGA Clinical Trials Hialeah Florida United States 33012
18 Sweet Hope Research Speciality, Inc. Miami Lakes Florida United States 33016
19 Leon Medical Research Corp. Miami Florida United States 33015
20 Elite Clinical Research Miami Florida United States 33144
21 DL Research Solutions Miami Florida United States 33155
22 Premier Research Associates, Inc. Miami Florida United States 33165
23 IMIC, Inc. Palmetto Bay Florida United States 33157
24 Atlanta Center for Clinical Research Nephrology Atlanta Georgia United States 30342
25 Columbus Regional Research Institute Columbus Georgia United States 31904
26 Gwinnett Biomedical Research Lawrenceville Georgia United States 30046
27 East Coast Institute for Clinical Research Macon Georgia United States 31210
28 East Coast Institute for Research Macon Georgia United States 31210
29 Saltzer Medical Group Nampa Idaho United States 83686
30 Research by Design, LLC Chicago Illinois United States 60643
31 American Health Network of Indiana Franklin Indiana United States 46131
32 My Kidney Center Manhattan Kansas United States 66502
33 Kentucky Diabetes Endocrinology Center Lexington Kentucky United States 40503
34 Joslin Diabetes Center Boston Massachusetts United States 02215
35 Aa Mrc, Llc Flint Michigan United States 48504
36 St. Louis Heart & Vascular, P.C. Saint Louis Missouri United States 63136
37 NJ Heart, P.A. Linden New Jersey United States 07036
38 Albany Medical College, Division of Community Endocrinology Albany New York United States 12206
39 Physicians East Endocrinology Greenville North Carolina United States 27834
40 Mountain View Clinical Research Greer South Carolina United States 29651
41 South Carolina Nephrology & Hypertension Center Orangeburg South Carolina United States 29118
42 University of Tennessee Health Science Center at Memphis University Hospital Memphis Tennessee United States 38104
43 Pioneer Research Solutions Beaumont Texas United States 77702
44 Academy of Diabetes, Thyroid and Endocrine, P.A. El Paso Texas United States 79935
45 The Medical Group of Texas Fort Worth Texas United States 76116
46 Rockwood Medical Center Fort Worth Texas United States 76164
47 Endocrine IPS, PLLC Houston Texas United States 77079
48 Pioneer Research Solutions, Inc. Houston Texas United States 77099
49 FMC Science, LLC Lampasas Texas United States 76550
50 Clinical Advancement Center PLLC San Antonio Texas United States 78215
51 Briggs Clinical Research San Antonio Texas United States 78224
52 Burke Internal Medicine and Research Burke Virginia United States 22015
53 Manassas Clinical Research Center Manassas Virginia United States 20110
54 Northside Endocrinology Spokane Washington United States 99208

Sponsors and Collaborators

  • Cyclerion Therapeutics

Investigators

  • Study Director: John Hanrahan, MD MPH, Cyclerion Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cyclerion Therapeutics
ClinicalTrials.gov Identifier:
NCT03217591
Other Study ID Numbers:
  • C1973-203
First Posted:
Jul 14, 2017
Last Update Posted:
Feb 5, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Albuminuria
Diabetes Mellitus, Type 2
Praliciguat

Study Results

No Results Posted as of Feb 5, 2021