Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Prokidney
Study ID
NCT05099770
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Renal Autologous Cell Therapy (REACT/ rilparencel) — BIOLOGICAL
    Participants will have a kidney biopsy followed approximately12 weeks later with a rilparencel injection into the biopsied kidney, then, approximately 12 weeks later a rilparencel injection into their contralateral kidney.
  • Sham Comparator — PROCEDURE
    Participants will have sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The 2 injection/ sham procedures will occur approximately 12 weeks apart.

Study Details

The purpose of this study is to assess the safety and efficacy of up to 2 REACT/rilparencel injections in participants with T2DM and CKD.

Key Dates

Start date
Jan 5, 2022
Status verified
Mar 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
685 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Sham Procedure
    Participants randomized to the Sham Comparator arm will have 2 sham procedures.
  • Experimental: Experimental (REACT/rilparencel injections)
    Participants randomized to the experimental arm will receive 2 injections of REACT/ rilparencel.

Primary Outcome Measure

Surrogate / Intermediate Efficacy Endpoint -eGFR Slope [ Time Frame: 18 months after the 135th participant receives their first injection / sham. ]

Central Contacts

Locations (79)

FacilityCityStateZIPSite coordinators
Nephrology ConsultantsHuntsvilleAlabama35805
David Baines, MD
256-827-5050
University of ArizonaTucsonArizona85724
Bijin Thajudeen, MD
520-626-0072
Amicis Research CenterBeverly HillsCalifornia90211-
Paradise Clinical Research Group LLCGlendoraCalifornia91741-
Kidney Consultants Medical GroupGranada HillsCalifornia91344-
IMD Clinical TrialsHuntington ParkCalifornia90255
Victor Carabello, MD
323-868-4400
Advanced Medical Research, LLCLakewoodCalifornia90712
Adarsh Daswani, MD
562-867-8195
Medicine and Nephrology AssociatesLos AlamitosCalifornia90720
Victor Kabbany, MD
562-596-1667
Academic Medical Research InstituteLos AngelesCalifornia90022
Mohamed El-Shahawy, MD
323-725-7149
Southern California HospitalLos AngelesCalifornia90095
Anjay Rastogi, MD
310-794-5024
Allameh Medical CorporationMission ViejoCalifornia92691-
Golden Pacific Nephrology Medical Clinic IncMonterey ParkCalifornia91755
Paul Hwu, MD
323-246-4955
Northridge Kidney Care CenterNorthridgeCalifornia91324-
Valley Clinical TrialsNorthridgeCalifornia91325
Christopher Chow, MD
818-280-4220
Valley Renal Medical GroupNorthridgeCalifornia91324
Renee Dua, MD
818-439-5031
Integrity Medical DiscoveryPico RiveraCalifornia90660-
National Institute of Clinical ResearchPomonaCalifornia91768
Tariq Shah, MD
909-766-8042
Nephrology Associates Medical GroupRiversideCalifornia92505
Dalia Dawoud, MD
951-529-1829
UC Davis Medical Group GI UnitSacramentoCalifornia95817
Prasanth Surampudi, MD
916-734-8802
Morgan Balaban
(916) 734 8802
North America Research InstituteSan DimasCalifornia91773
Aamir Jamal, MD
800-797-1695
Henry Mayo Newhall HospitalValenciaCalifornia91355-
Nephrology Associates PANewarkDelaware19713
Theodore Saad, MD
302-225-3618
West Broward Research InstituteCoral SpringsFlorida33313-
Florida Kidney PhysiciansFort LauderdaleFlorida33316-
South Fort Lauderdale NephrologyFort LauderdaleFlorida33316
Zachary Yablon, MD
516-851-2499
University of FloridaGainesvilleFlorida32608
Mark Segal, MD
352-265-4845
Mayo ClinicJacksonvilleFlorida32224
LaTonya Hickson, MD
904-953-3057
Ethos Palm BeachLoxahatchee GrovesFlorida33470
Sayed Ali, MD
561-783-8065
Global Clinix, LLCMiamiFlorida33155
Jeffrey Maldonado, MD
305-900-4431
Professional Research Center, Inc.MiamiFlorida33172
Jorge Posada, MD
786-359-4091
New Phase Clinical TrialsMiami BeachFlorida33140
Letica Adan, MD
305-858-4300
Infigo Clinical ResearchSanfordFlorida32771
Sayed Husain, MD
321-364-0728
Genesis Clinical ResearchTampaFlorida33603-
American Clinical TrialsAcworthGeorgia30101-
Wellstar Health SystemAugustaGeorgia30912
Laura Mulloy, DO
706-721-9547
Boise Kidney and Hypertension PLLCBoiseIdaho83706
Arnold Silva, MD
208-615-4395
Care InstituteChubbuckIdaho83202
Hira Siktel, MD
208-904-4780
Insight Hospital & Medical Center ChicagoChicagoIllinois60616
Rizwan Moinuddin, MD
312-567-2000
The University of Chicago Medical CenterChicagoIllinois60637-
Indiana NephrologyFishersIndiana46037
Ravneet Dhillon, MD
505-340-8101
Fresenius Kidney Care MishawakaMishawakaIndiana46545
Sudhir Vyakaranam, MD
574-273-6776
University of IowaIowa CityIowa52242
Mony Fraer, MD
319-356-4409
Nephrology Associates of LexingtonLexingtonKentucky40504
Muhammed Atiq, MD
859-276-2157
LSU Health Sciences CenterShreveportLouisiana71103
Bharat Sachdeva, MD
520-626-0072
Washington Nephrology AssociatesTakoma ParkMaryland20854-
Holyoke Medical CenterSpringfieldMassachusetts01107-
University of MichiganAnn ArborMichigan48109
Karthik Ramani, MD
734-615-1518
Nephrology Center, PCKalamazooMichigan49007
Ahmed Aqeel, MD
269-249-8445
St. Clair Nephrology ResearchRosevilleMichigan48066-
Southwest MS NephrologyBrookhavenMississippi39601
Paul Dykes, MD
601-835-4330
Nephrology AssociatesColumbusMississippi39705
Angela Riley, MD
662-329-3838
Nephrology and Hypertension AssociatesTupeloMississippi38801
Thomas Wooldridge, MD
662-844-4711
Saint Louis UniversitySt LouisMissouri63110-
Nevada Kidney Disease & Hypertension CenterLas VegasNevada89052-
Seacoast Kidney & Hypertension SpecialistsPortsmouthNew Hampshire03801
Sucharit Joshi, MD
603-436-3433
ICAHN School of Medicine at Mount SinaiNew YorkNew York10029
Steven Coca, MD
929-641-0971
NYU LangoneNew YorkNew York10017
Sindhuri Prakash-Polet, MD
646-501-8453
Jacobi Medical CenterThe BronxNew York10461
Anjali Acharya, MD
718-918-6212
UNC Chapel HillChapel HillNorth Carolina27514
Randy Detwiler, MD
919-843-0832
Lifespan Clinical Research CenterEast ProvidenceRhode Island02915
George Bayliss, MD
401-444-8728
Rhode Island HospitalProvidenceRhode Island02903-
Dunes Clinical ResearchDakota DunesSouth Dakota57049
Ashar Luqman, MD
605-217-7749
Knoxville Kidney CenterKnoxvilleTennessee37923
Kendra Hendon, MD
865-692-3462
Vanderbilt University Medical CenterNashvilleTennessee37232
Anna Burgner, MD
615-936-1179
Pioneer Research Solutions, Inc.CypressTexas77429
Rahul Pandey, MD
713-333-9323
Texas Tech Health SciencesEl PasoTexas79905-
Texas Tech University HealthEl PasoTexas79905-
Biopharma Informatic, LLCHoustonTexas77043-
Clinical Research Strategies, IncHoustonTexas77090
Christopher Kwoh, MD
Plaza NephrologyHoustonTexas77004
Justin Merszei, MD
713-520-6790
Prolato Clinical Research CenterHoustonTexas77054
Sreedhar Mandayam, MD
832-338-9118
United Memorial Medical CenterHoustonTexas77091
Wasae Tabibi, MD
281-618-8500
Clinical Advancement Center, PLLCSan AntonioTexas78212
Pablo Pergola, MD
210-223-4444
University Health SystemSan AntonioTexas78229
Shweta Bansal, MD
210-743-6450
Prolato Clinical Research Center - Sugar LandSugar LandTexas77479
Biruh Workeneh, MD
832-338-9118
Renal Physicians of Montgomery CountyThe WoodlandsTexas77384
Harini Bejjanki, MD
936-331-8456
Salem VA Medical CenterSalemVirginia24153
Devasmita Dev, MD
540-982-2463
Providence Medical Research CtrSpokaneWashington99204
Radica Alicic, MD
509-474-4345
University of Wisconsin-MadisonMadisonWisconsin53792
Ali Gardezi, MD
608-608-6400

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