Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease



Status:Active, not recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:September 17, 2015
End Date:May 25, 2020

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

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to
standard daily therapy, is effective and safe in treating patients with type 2 diabetes
mellitus and diabetic kidney disease, when compared to a placebo.


Inclusion Criteria:

- Men or women ≥18 years of age

- Subjects with Type 2 diabetes mellitus as defined by the American Diabetes Association

- Diagnosis of diabetic kidney disease (DKD) with persistent high albuminuria or
persistent very high albuminuria at the Run-in and Screening visits:

- Pretreated with either angiotensin-converting enzyme inhibitor(ACEI) or angiotensin
receptor blocker (ARB) at maximal tolerated labeled dose without adjustments

- Serum potassium <=4.8 mmol/L.

Exclusion Criteria:

- Confirmed significant non-diabetic renal disease, including clinically relevant renal
artery stenosis

- Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP)
≥170 mmHg, sitting diastolic blood pressure (DBP) ≥110 mmHg at run in visit, or mean
sitting SBP ≥160 mmHg, sitting DBP ≥100 mmHg at screening)

- Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and
persistent symptoms New York Heart Association (NYHA class II - IV) at run in visit
(class 1A recommendation for mineralcorticoid receptor antagonist (MRAs)

- Dialysis for acute renal failure within 12 weeks of run in visit

- Renal allograft in place or scheduled kidney transplant within next 12 months

- Glycated hemoglobin HbA1c > 12%.
We found this trial at
169
sites
643
mi
from
Indianapolis, IN
Click here to add this to my saved trials
1306
mi
from
Albany, NY
Click here to add this to my saved trials
523
mi
from
Albuquerque, NM
Click here to add this to my saved trials
1126
mi
from
Alexandria, VA
Click here to add this to my saved trials
874
mi
from
Anderson, SC
Click here to add this to my saved trials
808
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
353
mi
from
Arlington, TX
Click here to add this to my saved trials
1177
mi
from
Arvin, CA
Click here to add this to my saved trials
?
mi
from
Asheboro, NC
Click here to add this to my saved trials
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
932
mi
from
Augusta, GA
Click here to add this to my saved trials
957
mi
from
Beaver, PA
Click here to add this to my saved trials
1215
mi
from
Bethlehem, PA
Click here to add this to my saved trials
683
mi
from
Birmingham, AL
Click here to add this to my saved trials
1444
mi
from
Boston, MA
Click here to add this to my saved trials
1287
mi
from
Brooklyn, NY
Click here to add this to my saved trials
1356
mi
from
Burlington, VT
Click here to add this to my saved trials
900
mi
from
Canton, OH
Click here to add this to my saved trials
1043
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29412
1064
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
959
mi
from
Charlotte, NC
Click here to add this to my saved trials
719
mi
from
Chattanooga, TN
Click here to add this to my saved trials
610
mi
from
Chicago, IL
Click here to add this to my saved trials
610
mi
from
Chicago, IL
Click here to add this to my saved trials
1140
mi
from
Chula Vista, CA
Click here to add this to my saved trials
1140
mi
from
Chula Vista, CA
Click here to add this to my saved trials
895
mi
from
Cleveland, OH
Click here to add this to my saved trials
310
mi
from
Columbia, MO
Click here to add this to my saved trials
310
mi
from
Columbia, MO
Click here to add this to my saved trials
810
mi
from
Columbus, OH
Click here to add this to my saved trials
688
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
349
mi
from
Dallas, TX
Click here to add this to my saved trials
349
mi
from
Dallas, TX
Click here to add this to my saved trials
349
mi
from
Dallas, TX
Click here to add this to my saved trials
1314
mi
from
Dublin, CA
Click here to add this to my saved trials
807
mi
from
Duluth, GA
Click here to add this to my saved trials
1055
mi
from
El Centro, CA
Click here to add this to my saved trials
641
mi
from
El Paso, TX
Click here to add this to my saved trials
585
mi
from
Elgin, IL
Click here to add this to my saved trials
1061
mi
from
Fleming Island, FL
Click here to add this to my saved trials
822
mi
from
Flint, MI
Click here to add this to my saved trials
1296
mi
from
Flushing, NY
Click here to add this to my saved trials
1307
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
712
mi
from
Fort Payne, AL
Click here to add this to my saved trials
1210
mi
from
Fresno, CA
Click here to add this to my saved trials
1210
mi
from
Fresno, CA
Click here to add this to my saved trials
1047
mi
from
Gainesville, FL
Click here to add this to my saved trials
Greenville, North Carolina 27834
1139
mi
from
Greenville, NC
Click here to add this to my saved trials
Greenville, South Carolina 29605
882
mi
from
Greenville, SC
Click here to add this to my saved trials
889
mi
from
Greer, SC
Click here to add this to my saved trials
1147
mi
from
Hershey, PA
Click here to add this to my saved trials
1314
mi
from
Hialeah, FL
Click here to add this to my saved trials
1309
mi
from
Hollywood, FL
Click here to add this to my saved trials
3718
mi
from
Honolulu, HI
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
660
mi
from
Huntsville, AL
Click here to add this to my saved trials
22
mi
from
Hutchinson, KS
Click here to add this to my saved trials
429
mi
from
Iowa City, IA
Click here to add this to my saved trials
1053
mi
from
Jacksonville, FL
Click here to add this to my saved trials
307
mi
from
Jefferson City, MO
Click here to add this to my saved trials
5529
mi
from
Junín,
Click here to add this to my saved trials
198
mi
from
Kansas City, MO
Click here to add this to my saved trials
198
mi
from
Kansas City, MO
Click here to add this to my saved trials
552
mi
from
Kingwood, TX
Click here to add this to my saved trials
1133
mi
from
La Mesa, CA
Click here to add this to my saved trials
1219
mi
from
Lansdale, PA
Click here to add this to my saved trials
971
mi
from
Las Vegas, NV
Click here to add this to my saved trials
971
mi
from
Las Vegas, NV
Click here to add this to my saved trials
810
mi
from
Lilburn, GA
Click here to add this to my saved trials
219
mi
from
Lincoln, NE
Click here to add this to my saved trials
1114
mi
from
Loma Linda, CA
Click here to add this to my saved trials
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
871
mi
from
Macon, GA
Click here to add this to my saved trials
1101
mi
from
Manassas, VA
Click here to add this to my saved trials
797
mi
from
McAllen, TX
Click here to add this to my saved trials
324
mi
from
McKinney, TX
Click here to add this to my saved trials
467
mi
from
Memphis, TN
Click here to add this to my saved trials
841
mi
from
Mesa, AZ
Click here to add this to my saved trials
690
mi
from
Metairie, LA
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials