Multicenter, Uncontrolled Pilot Study Evaluating the Efficacy of Eculizumab in the Treatment of Gemcitabine-induced Thrombotic Microangiopathies

University Hospital, Rouen2 sites in 1 country10 target enrollmentMarch 2023

ConditionsThrombotic Microangiopathies

InterventionsEculizumab administration

DrugsEculizumab administration

Overview

Phase: Phase 3
Intervention: Eculizumab administration
Conditions: Thrombotic Microangiopathies
Sponsor: University Hospital, Rouen
Enrollment: 10
Locations: 2
Primary Endpoint: Time from initiation of eculizumab treatment to renal remission
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of this prospective multisite trial is to study the evolution of TMA (thrombotic microangiopathy) induced by gemcitabin and treated by eculizumab.

Registry

clinicaltrials.gov

Start Date

March 2023

End Date

September 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Rouen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years old
•Previous treatment with gemcitabine within the last 18 months (duration of treatment ≥ 3 consecutive months and cumulative dose should be ≥ 10 grams).
•Neoplasia in remission or not in remission but with an estimated life expectancy \> 6 months
•Acute renal failure defined by 1 of the following 2 criteria : Creatinine \> 2 times baseline creatinine and/or diuresis \< 0.5 ml/kg/h for 12 hours.
•Clinical and biological criteria for thrombotic microangiopathy: mechanical hemolytic anemia and/or tThrombocytopeniaPatient affiliated with a social security system,
•Adult patient or representative of the adult patient who has read and understood the information letter and signed the consent form.
•Woman of childbearing age with effective contraception as defined by the WHO (estrogen-progestin or intrauterine device or tubal ligation) for more than one month and a negative -HCG pregnancy test at baseline, for the duration of the study and for at least 5 months after the end of the treatment, or Postmenopausal woman (non-medically induced amenorrhea for at least 12 months prior to the baseline visit) or For men, use of protection during sexual intercourse for the duration of the study and for at least 60 days after the end of study treatment

Exclusion Criteria

•Progressive neoplasia with a life expectancy of \<6 months
•Patient with a contraindication to the administration of the treatment experienced: SOLIRIS® 300 mg concentrate for solution for infusion
•Contraindication to antibiotic prophylaxis
•Thrombotic microangiopathy associated with cancer (metastatic adenocarcinoma with bone marrow invasion, erythromyelemia, disseminated intravascular coagulation)
•Active systemic bacterial infection, untreated or confirmed sepsis (positive blood cultures within 7 days of patient inclusion and not treated with effective antibiotic therapy)
•Unresolved meningococcal infection
•Patient not vaccinated against meningococcal infection
•Pregnant or breastfeeding woman or proven lack of contraception
•Known systemic lupus erythematosus
•Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship