Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation
NCT ID: NCT04294459
Last Updated: 2025-09-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
23 participants
INTERVENTIONAL
2020-06-18
2022-05-02
Brief Summary
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* Phase 1: To characterize the safety and tolerability of isatuximab in kidney transplant candidates.
* Phase 2: To evaluate the efficacy of isatuximab in desensitization of participants awaiting kidney transplantation.
Secondary Objectives:
* Phase 2: To characterize the safety profile of isatuximab in kidney transplant candidates.
* To characterize the pharmacokinetic (PK) profile of isatuximab in kidney transplant candidates.
* To evaluate the immunogenicity of isatuximab.
* To assess the overall efficacy of isatuximab in desensitization of participants awaiting kidney transplantation.
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Detailed Description
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The study duration involved site visit per participant (i.e., screening, treatment, site visit FUP was approximately 42 weeks.
The study duration included extended FUP per participant was approximately 97.7 weeks (depending on when the participant was enrolled).
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort A: Participants with cPRA >=99.90%
Participants with calculated panel reactive antibodies (cPRA) \>=99.90% (indicating active candidates on kidney transplant waitlist) received isatuximab 10 milligrams per kilogram (mg/kg), intravenous (IV) infusion, once weekly (QW) for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then every 2 weeks (Q2W) for subsequent treatment cycles (each cycle of 28 days) until unacceptable adverse events (AEs) or participant's decision to stop the treatment (maximum treatment duration: 13 weeks).
Isatuximab SAR650984
Pharmaceutical form: Solution for infusion
Route of administration: Intravenous
Acetaminophen (paracetamol) or equivalent
Pharmaceutical form: Tablets
Route of administration: Oral
Ranitidine or equivalent
Pharmaceutical form: Solution
Route of administration: Intravenous
Diphenhydramine or equivalent
Pharmaceutical form: Solution
Route of administration: Intravenous
Methylprednisolone or equivalent
Pharmaceutical form: Solution
Route of administration: Intravenous
Montelukast or equivalent
Pharmaceutical form: Tablets
Route of administration: Oral
Cohort B: Participants with cPRA 80.00% to 99.89%
Participants with cPRA between 80.00% to 99.89% (indicating active candidates on kidney transplant waitlist with no living donor cleared for donation) received isatuximab 10 mg/kg, IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1) and then Q2W for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs or participant's decision to stop the treatment (maximum treatment duration: 13 weeks).
Isatuximab SAR650984
Pharmaceutical form: Solution for infusion
Route of administration: Intravenous
Acetaminophen (paracetamol) or equivalent
Pharmaceutical form: Tablets
Route of administration: Oral
Ranitidine or equivalent
Pharmaceutical form: Solution
Route of administration: Intravenous
Diphenhydramine or equivalent
Pharmaceutical form: Solution
Route of administration: Intravenous
Methylprednisolone or equivalent
Pharmaceutical form: Solution
Route of administration: Intravenous
Montelukast or equivalent
Pharmaceutical form: Tablets
Route of administration: Oral
Interventions
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Isatuximab SAR650984
Pharmaceutical form: Solution for infusion
Route of administration: Intravenous
Acetaminophen (paracetamol) or equivalent
Pharmaceutical form: Tablets
Route of administration: Oral
Ranitidine or equivalent
Pharmaceutical form: Solution
Route of administration: Intravenous
Diphenhydramine or equivalent
Pharmaceutical form: Solution
Route of administration: Intravenous
Methylprednisolone or equivalent
Pharmaceutical form: Solution
Route of administration: Intravenous
Montelukast or equivalent
Pharmaceutical form: Tablets
Route of administration: Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) \</=40 kg/m\^2.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Capable of giving signed informed consent.
For Participants in Cohort A: active candidates on the kidney waitlist with living donor.
For Participants in Cohort B: active candidates on the kidney waitlist with no living donor cleared for donation.
Exclusion Criteria
* Known active, recurrent, or chronic infection.
* Active lupus or uncontrolled diabetes.
* Prior treatment with rituximab within 6 months from SAR650984 administration.
* Inadequate organ and bone marrow function at screening.
* Pregnant or breastfeeding women or women who intend to become pregnant during participation in the study.
* Known intolerance or hypersensitivity to any component of SAR650984 or pre-medications.
* Participants who were not suitable for participation as judged by the Investigator.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
70 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number :8400003
San Francisco, California, United States
Investigational Site Number :8400001
Rochester, Minnesota, United States
Investigational Site Number :8400002
New York, New York, United States
Investigational Site Number :8400004
Houston, Texas, United States
Investigational Site Number :7240002
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number :7240001
L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain
Countries
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References
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Mannon RB, Vincenti FG. Poised for Innovation: Considerations for End Points for New Drug Development in Kidney Transplantation. J Am Soc Nephrol. 2024 Nov 1;35(11):1603-1606. doi: 10.1681/ASN.0000000000000475. Epub 2024 Aug 5. No abstract available.
Vincenti F, Bestard O, Brar A, Cruzado JM, Seron D, Gaber AO, Ali N, Tambur AR, Lee H, Abbadessa G, Paul JA, Dudek M, Siegel RJ, Torija A, Semiond D, Lepine L, Ternes N, Montgomery RA, Stegall M. Isatuximab Monotherapy for Desensitization in Highly Sensitized Patients Awaiting Kidney Transplant. J Am Soc Nephrol. 2024 Mar 1;35(3):347-360. doi: 10.1681/ASN.0000000000000287. Epub 2023 Dec 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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TED16414 Plain Language Results Summary
Other Identifiers
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2019-004154-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1238-9716
Identifier Type: OTHER
Identifier Source: secondary_id
TED16414
Identifier Type: -
Identifier Source: org_study_id
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