What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials?
Julie Lin, Jai Radhakrishnan
https://pubmed.ncbi.nlm.nih.gov/39899371Actively Recruiting
Phase 2
Age: 16Years - 75Years
All Genders
ID06500702
A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
Led by Sanofi · Updated on 2026-06-08
84
Participants Needed
71
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of three drugs—frexalimab, brivekimig, and rilzabrutinib—compared with placebo for treating primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD) in people aged 16 to 75 years. This phase 2a study aims to measure how these treatments change proteinuria and affect remission rates of nephrotic syndrome in participants with these kidney conditions. The study is a randomized, double-blind trial with six parallel groups. Participants will receive either frexalimab, brivekimig, rilzabrutinib, or matching placebo. Treatment lasts for 24 weeks, during which participants will have up to 18 visits. The total study duration can be up to 76 weeks. Participants will undergo evaluations including urine protein to creatinine ratio tests to measure proteinuria changes from baseline to week 12. Researchers will also monitor remission rates, adverse events, blood concentrations of the study drugs, and immune responses up to week 48. The study includes safety assessments and regular follow-up visits to track participant health and treatment effects throughout the study period.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
Who Can Participate
Age: 16Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Biopsy report showing primary FSGS or primary minimal change disease with supportive clinical presentation
- Urine protein to creatinine ratio (UPCR) of at least 3 g/g at screening, or at least 1.5 g/g if estimated glomerular filtration rate (eGFR) is 60 or higher
- eGFR of 45 mL/min/1.73 m² or higher at screening
- Documented history of over 40% reduction in UPCR or 24-hour urine protein with corticosteroid or immunosuppressive therapy when pre-treatment UPCR was at least 3.5 g/g
- Stable dose of prednisone 10 mg/day or less starting at least one week before randomization
- Stable dose of RAAS inhibitor for at least 4 weeks before screening if used
- Stable dose of SGLT2 inhibitor for at least 4 weeks before screening if used
- Body weight between 45 and 120 kg inclusive at screening
You will not qualify if you...
- Genetic or secondary FSGS or minimal change disease (except those with APOL1 risk alleles)
- Collapsing variant of FSGS
- End-stage kidney disease requiring dialysis or transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening assessments
Treatment
Duration - Up to 48 weeks
Participants receive frexalimab, brivekimig, rilzabrutinib, or placebo to evaluate efficacy and safety.
Regular visits during treatment up to Week 48
Trial Site Locations
Total: 71 locations
1
Investigational Site Number : 8400007
Birmingham, Alabama, United States, 35233
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2
Investigational Site Number : 8400015
Orange, California, United States, 92868
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3
Investigational Site Number : 8400012
San Francisco, California, United States, 94143
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4
Investigational Site Number : 8400025
Tampa, Florida, United States, 33612
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5
Emory Children's Center- Site Number : 8400020
Atlanta, Georgia, United States, 30322
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6
Investigational Site Number : 8400014
Chicago, Illinois, United States, 60611
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7
Investigational Site Number : 8400017
Hinsdale, Illinois, United States, 60521
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8
Investigational Site Number : 8400010
Ann Arbor, Michigan, United States, 48109
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9
Investigational Site Number : 8400019
Edina, Minnesota, United States, 55435
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10
Investigational Site Number : 8400018
Las Vegas, Nevada, United States, 89107
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11
Investigational Site Number: 8400028
Albuquerque, New Mexico, United States, 87109
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12
Investigational Site Number : 8400001
New York, New York, United States, 10032
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13
Investigational Site Number : 8400021
Chapel Hill, North Carolina, United States, 27599
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14
Investigational Site Number : 8400024
Dallas, Texas, United States, 75204
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15
Investigational Site Number : 8400005
El Paso, Texas, United States, 79902
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16
Investigational Site Number: 8400016
Houston, Texas, United States, 77054
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17
Investigational Site Number : 0320001
Buenos Aires, Argentina, 1431
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18
Investigational Site Number : 0320002
Córdoba, Argentina, 5016
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19
Investigational Site Number : 0360003
Garran, Australian Capital Territory, Australia, 2605
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20
Investigational Site Number : 0360001
Parkville, Victoria, Australia, 3050
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21
Investigational Site Number: 0760004
Botucatu, São Paulo, Brazil, 18618-970
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22
Synvia Clinical- Site Number : 0760005
São Paulo, São Paulo, Brazil, 01139-000
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23
Investigational Site Number : 0760002
São Paulo, Brazil, 04038-002
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24
Investigational Site Number : 0760001
São Paulo, Brazil, 05403-000
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25
Investigational Site Number : 1240002
London, Ontario, Canada, N6A 5A5
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26
Investigational Site Number : 1240001
Montreal, Quebec, Canada, H1T 2M4
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27
Investigational Site Number : 1240005
Montreal, Quebec, Canada, H3T 1C5
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28
Investigational Site Number : 1240006
Québec, Quebec, Canada, G1R 2J6
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29
Investigational Site Number : 1520003
Temuco, La Araucanía, Chile, 4781151
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30
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile, 8330034
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31
Investigational Site Number : 1560001
Beijing, China, 100034
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32
Investigational Site Number : 1560003
Chengdu, China, 610072
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33
Investigational Site Number : 1560004
Shanghai, China, 200080
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34
Investigational Site Number : 2030002
Olomouc, Czechia, 779 00
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35
Investigational Site Number : 2030001
Prague, Czechia, 128 08
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36
Investigational Site Number : 2500002
Créteil, France, 94010
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37
Investigational Site Number : 2500001
Paris, France, 75015
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38
Investigational Site Number : 2760002
Berlin, Germany, 10117
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39
Investigational Site Number : 2760006
Dresden, Germany, 01307
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40
Investigational Site Number : 2760003
Hanover, Germany, 30625
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41
Investigational Site Number : 3000002
Athens, Greece, 115 27
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42
Investigational Site Number : 3000001
Heraklion, Greece, 711 10
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43
Investigational Site Number : 3000003
Ioannina, Greece, 455 00
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44
Investigational Site Number : 3480001
Budapest, Hungary, 1085
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45
Investigational Site Number : 3800002
Florence, Firenze, Italy, 50134
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46
Investigational Site Number : 3800003
Naples, Napoli, Italy, 80131
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47
Investigational Site Number : 3800001
Brescia, Italy, 25123
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48
Investigational Site Number : 4840005
Mexico City, Mexico City, Mexico, 06720
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49
Investigational Site Number : 4840001
Mexico City, Mexico City, Mexico, 14080
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50
Investigational Site Number : 4840003
Monterrey, Nuevo León, Mexico, 64460
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51
Investigational Site Number : 5280001
Amsterdam, Netherlands, 1105 AZ
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52
Investigational Site Number : 6160004
Poznan, Greater Poland Voivodeship, Poland, 60-780
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53
Investigational Site Number : 6160001
Lodz, Lódzkie, Poland, 02-213
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54
Investigational Site Number : 6160002
Opole, Opole Voivodeship, Poland, 45-418
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55
Investigational Site Number : 6200003
Lisbon, Portugal, 1050-099
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56
Investigational Site Number : 6200002
Porto, Portugal, 4434-502
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57
Investigational Site Number : 7030003
Banská Bystrica, Slovakia, 975 17
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58
Investigational Site Number : 7030004
Bratislava - Kramare, Slovakia, 831 01
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59
Investigational Site Number : 7030001
Martin, Slovakia, 036 01
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60
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], Spain, 08035
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61
Investigational Site Number : 7240005
Seville, Sevilla, Spain, 41013
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62
Investigational Site Number : 7240002
Córdoba, Spain, 14004
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63
Investigational Site Number : 7240008
Madrid, Spain, 28007
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64
Investigational Site Number : 7240007
Madrid, Spain, 28040
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65
Investigational Site Number : 1580001
Taichung, Taiwan, 404
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66
Investigational Site Number : 1580002
Taipei, Taiwan, 100
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67
Investigational Site Number : 7920001
İzmit, Turkey (Türkiye), 41001
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68
Investigational Site Number : 7920002
Kayseri, Turkey (Türkiye), 38039
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69
Investigational Site Number : 8260001
Leicester, Leicestershire, United Kingdom, LE5 4PW
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70
Investigational Site Number : 8260004
Salford, Manchester, United Kingdom, M6 8HD
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71
Investigational Site Number : 8260005
Oxford, Oxfordshire, United Kingdom, OX3 7LE
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Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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