Study of RG-012 in Male Subjects With Alport Syndrome



Status:Suspended
Conditions:Nephrology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 60
Updated:1/26/2019
Start Date:November 7, 2017
End Date:December 2019

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of RG-012 for Injection Administered Every 2 Weeks in Patients With Alport Syndrome

This is a randomized, double-blind, placebo-controlled, multi-center, Phase 2 study of the
safety and efficacy of RG-012 administered to male subjects with Alport syndrome.

This is a randomized, double-blind, placebo-controlled, multi-center, Phase 2 study of RG-012
in male subjects with Alport syndrome. Eligible subjects will be randomized in a 1:1 ratio to
receive subcutaneous (SC) injections of RG-012 or placebo every other week for 48 weeks.
After completion of this double-blind treatment period, subjects will have the opportunity to
receive RG-012 in a 48 week open-label extension period.

Male subjects with a confirmed diagnosis of Alport syndrome and a baseline GFR between 40 and
90 mL/min/1.73m2 will be eligible for enrollment. Subjects may enter this study directly or
may enroll after participation in the RG012-01 ATHENA Natural History Study.

Subjects may continue treatment with angiotensin converting enzyme (ACE) inhibitors or
angiotensin II receptor blockers (ARBs), but must be on a stable dosing regimen for the 30
days prior to screening.

Inclusion Criteria:

1. Male, age 18 to 60 years (inclusive)

2. Confirmed diagnosis of Alport syndrome (clinical and genetic)

3. eGFR between 40 and 90 mL/min/1.73m2

4. Proteinuria ≥ 300 mg protein/g creatinine at screening

5. For subjects taking an ACE inhibitor and/or ARB, the dosing regimen should be stable
for at least 30 days prior to screening

Exclusion Criteria:

1. Causes of chronic kidney disease aside from Alport syndrome (such as diabetic
nephropathy, hypertensive nephropathy, lupus, or IgA nephropathy)

2. End stage renal disease (ESRD) as evidenced by ongoing dialysis therapy or a history
of renal transplantation

3. Weight > 110 kg (242.5 pounds)

4. Any other condition that may pose a risk to the subject's safety and well-being
We found this trial at
23
sites
201 Presidents Cir
Salt Lake City, Utah 84107
Principal Investigator: Sanjiv Anand, M.D.
Phone: 801-747-9186
572
mi
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Salt Lake City, UT
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Michelle Rheault, M.D.
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
1511
mi
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Minneapolis, MN
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825 South 8th Street
Minneapolis, Minnesota 55404
888-345-2567
Principal Investigator: Jeffrey Connaire, M.D.
1509
mi
from 91732
Minneapolis, MN
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Alexandria, Virginia 22304
Principal Investigator: Bala Subramanian, M.D.
Phone: 410-952-5307
2281
mi
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Alexandria, VA
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Arvada, Colorado 80002
Principal Investigator: Rajesh Yalavarthy, M.D.
Phone: 720-689-2215
815
mi
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Arvada, CO
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Bellevue, Washington 98004
Principal Investigator: Allen Geltzer, M.D.
960
mi
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Bellevue, WA
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Bronx, New York 10461
Principal Investigator: Gill Frei, M.D.
2436
mi
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Bronx, NY
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395 West 12th Avenue
Columbus, Ohio 43210
Principal Investigator: Isabelle Ayoub, M.D.
1959
mi
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Columbus, OH
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21216 Northwest Freeway
Cypress, Texas 77429
Principal Investigator: Rupi K Chatha, M.D.
1339
mi
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Cypress, TX
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Dallas, Texas 75231
Principal Investigator: Sumit Kumar, M.D.
1225
mi
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Dallas, TX
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Dallas, Texas 75235
Principal Investigator: Ankit N. Mehta, M.D.
1220
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Dallas, TX
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Kansas City, Missouri 64111
Principal Investigator: Ahmed Awad, M.D.
1341
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Kansas City, MO
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La Mesa, California 91942
Principal Investigator: J. Scott Overcash, M.D.
Phone: 619-567-1550
106
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La Mesa, CA
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Lansdale, Pennsylvania 19446
Principal Investigator: Jack Rosenfeld, M.D.
2367
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Lansdale, PA
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Lawrenceville, Georgia 30046
Principal Investigator: James Tumlin, M.D.
1939
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Lawrenceville, GA
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Los Angeles, California 90022
Principal Investigator: Mohamed El-Shahawy, M.D.
Phone: 323-725-0051
8
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Los Angeles, CA
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Riverside, California
Principal Investigator: Chao H. Sun, M.D.
37
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Riverside, CA
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Roseville, Michigan 48066
Principal Investigator: Joel Topf, M.D.
1973
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Roseville, MI
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: George Jarad, M.D.
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
1569
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Saint Louis, MO
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San Antonio, Texas 78229
Principal Investigator: Wesley Calhoun, M.D.
1188
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San Antonio, TX
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Tampa, Florida 33604
Principal Investigator: Cecilio Hernandez, M.D.
Phone: 813-443-8487
2136
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Tampa, FL
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Wauwatosa, Wisconsin 53226
Principal Investigator: Andrew Kim, M.D.
Phone: 414-727-8131
1724
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Wauwatosa, WI
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Westminster, Colorado 80031
Principal Investigator: Jospeh G. Abdallah, M.D.
Phone: 720-689-2964
818
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Westminster, CO
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