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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Endocrine, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:25 - 75
Updated:4/5/2019
Start Date:August 1, 2017
End Date:October 2019
Contact:Paul Miller
Email:pmiller@cyclerion.com
Phone:857-338-3355

Use our guide to learn which trials are right for you!

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

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.


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 <3000 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 180 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.
We found this trial at
54
sites
Newark, Delaware 19713
Phone: 302-623-3844
?
mi
from
Newark, DE
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-934-4112
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
900 W 49th St # 430
Hialeah, Florida 33012
Phone: 305-819-1551
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Albany, New York 12206
Phone: 518-264-4723
?
mi
from
Albany, NY
Click here to add this to my saved trials
5673 Ptree Dun Rd NE
Atlanta, Georgia 30342
Phone: 404-252-4486
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
10700 Stancliff Road
Beaumont, Texas 77702
Phone: 713-333-9323
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Phone: 617-309-2477
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Burke, Virginia 22015
Phone: 703-455-9711
?
mi
from
Burke, VA
Click here to add this to my saved trials
9730 South Western Avenue
Chicago, Illinois 60643
Phone: 708-952-4644
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chula Vista, California 91910
Phone: 619-422-2687
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Columbus, Georgia 31904
Phone: 706-321-0495
?
mi
from
Columbus, GA
Click here to add this to my saved trials
Denver, Colorado 80209
Phone: 303-388-6410
?
mi
from
Denver, CO
Click here to add this to my saved trials
10525 Vista Del Sol Drive
El Paso, Texas 79935
Phone: 915-633-9387
?
mi
from
El Paso, TX
Click here to add this to my saved trials
1201 Flushing Road
Flint, Michigan 48504
Phone: 810-237-1125
?
mi
from
Flint, MI
Click here to add this to my saved trials
1217 Grand Avenue
Fort Worth, Texas 76164
Phone: 817-625-7733
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fort Worth, Texas 76104
Phone: 817-348-8292
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Franklin, Indiana 46131
Phone: 317-738-7497
?
mi
from
Franklin, IN
Click here to add this to my saved trials
Fullerton, California 92835
Phone: 714-446-5950
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Greenville, North Carolina 27834
Phone: 252-413-6232
?
mi
from
Greenville, NC
Click here to add this to my saved trials
Greer, South Carolina 29651
Phone: 864-334-0141
?
mi
from
Greer, SC
Click here to add this to my saved trials
Houston, Texas 77098
Phone: 713-333-9323
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77079
Phone: 713-973-3415
?
mi
from
Houston, TX
Click here to add this to my saved trials
La Mesa, California 91942
Phone: 619-461-3894
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
207 West Avenue East
Lampasas, Texas 76550
Phone: 512-556-4130
?
mi
from
Lampasas, TX
Click here to add this to my saved trials
Lawrenceville, Georgia 30046
Phone: 678-942-5986
?
mi
from
Lawrenceville, GA
Click here to add this to my saved trials
Lexington, Kentucky 40503
Phone: 859-278-2232
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Linden, New Jersey 07036
Phone: 908-275-4982
?
mi
from
Linden, NJ
Click here to add this to my saved trials
Lomita, California 90717
Phone: 424-203-8984
?
mi
from
Lomita, CA
Click here to add this to my saved trials
Los Angeles, California 90017
Phone: 213-481-7142
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90022
Phone: 323-725-0051
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Macon, Georgia 31210
Phone: 478-746-8626
?
mi
from
Macon, GA
Click here to add this to my saved trials
?
mi
from
Macon, GA
Click here to add this to my saved trials
Manassas, Virginia 20110
Phone: 703-330-1112
?
mi
from
Manassas, VA
Click here to add this to my saved trials
1149-1167 College Avenue
Manhattan, Kansas 66502
Phone: 785-565-9500
?
mi
from
Manhattan, KS
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
101 Southwest 27th Avenue
Miami, Florida 33015
Phone: 305-823-4002
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33144
Phone: 305-262-3396
?
mi
from
Miami, FL
Click here to add this to my saved trials
7483 Southwest 24th Street
Miami, Florida 33155
Phone: 786-350-9764
?
mi
from
Miami, FL
Click here to add this to my saved trials
387 Shuman Boulevard
Miami, Florida 33165
Phone: 786-360-4219
?
mi
from
Miami, FL
Click here to add this to my saved trials
14160 Palmetto Frontage Road
Miami Lakes, Florida 33016
Phone: 305-456-9062
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
Nampa, Idaho 83686
Phone: 208-288-4923
?
mi
from
Nampa, ID
Click here to add this to my saved trials
18531 Roscoe Boulevard
Northridge, California 91324
Phone: 818-349-1979
?
mi
from
Northridge, CA
Click here to add this to my saved trials
Orangeburg, South Carolina 29118
Phone: 803-531-2220
?
mi
from
Orangeburg, SC
Click here to add this to my saved trials
Palmetto Bay, Florida
Phone: 786-310-7477
?
mi
from
Palmetto Bay, FL
Click here to add this to my saved trials
3595 van buren
Riverside, California 92503
Phone: 800-797-1696
?
mi
from
Riverside, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63136
Phone: 314-741-0911
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78224
Phone: 210-924-9435
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78215
Phone: 210-223-4444
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Dimas, California 91970
Phone: 800-797-1695
?
mi
from
San Dimas, CA
Click here to add this to my saved trials
San Dimas, California 91773
Phone: 800-797-1695
?
mi
from
San Dimas, CA
Click here to add this to my saved trials
Santa Monica, California 90404
Phone: 310-954-2692
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
6120 North Mayfair Street
Spokane, Washington 99208
Phone: 509-444-7665
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Torrance, California 90502
Phone: 310-781-3622
?
mi
from
Torrance, CA
Click here to add this to my saved trials
Washington, District of Columbia 20037
Phone: 202-741-2259
?
mi
from
Washington,
Click here to add this to my saved trials