NCT02374736

Effect of Privigen Against Graft Loss

A Pilot Study on the Effect of Privigen Against Graft Loss: Interventional Study of Kidney Transplant Recipients at Risk for Graft Loss Through Antibody-mediated Rejection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The principal objective of this pilot study is to determine whether the progression of chronic antibody-mediated rejection (ABMR) could be minimized by the post-transplant administration of high dose of Intravenous Immunoglobulins (IVIg). We test the hypothesis that repetitive IVIg administration reduces or stabilize the progressive loss of transplant function and the evolution to chronic ABMR in stable kidney transplant patients with HLA-DSA developed post-transplantion (de novo HLA-DSA) and concomitant humoral graft injury.

Detailed description

The aim of this study is to assess the effect of IVIg associated to conventional immunosuppressive treatment in 15 stable transplant recipients with post-transplant de novo HLA-DSA and histological humoral lesions. The study will include 2 periods: * Treatment period, * Follow-up period. The treatment will start the day of inclusion (M0): Privigen will be given as 2 g/kg for 2 days/month for 6 months (maximum dose: 80 g/day). Evaluation at the end of treatment will take place on month 6 (M6). Evaluation at the end of follow up will take place on month 12 (M12). Blood and urine samples will be collected on day of inclusion (M0), before each infusion of Privigen, at M6 and M12 for biological analysis (serum creatinine, glomerular filtration rate, proteinuria). Blood samples will be collected on day of inclusion (M0), at M6 and M12 for immunoassay (HLA-DSA mean fluorescence intensity). Blood sample will be collected on day of inclusion (M0) to provide a DNA bank. Blood samples will be collected on day of inclusion (M0), before each infusion of Privigen and at M6 for IgG dosage. Blood samples will be collected on day of inclusion (M0), before each infusion of Privigen, at M6 and M12 to provide a serum bank. Blood samples will be collected on day of inclusion (M0), before each infusion of Privigen, at M6 and M12 for haematology, blood chemistry and Coombs test. Histological characteristics (kidney biopsies) will be performed on M0 and M6. The M6 biopsy is specifically requested by the protocol and differs from the usual practice, where it is usually performed at M12 post transplantation. Infectious and clinical events (deceased patients, graft loss, acute biopsy-proven rejection episode and infectious diseases) will be recorded during the follow-up period. Histology of for-cause biopsies will be performed according to center practice. We recommend a graft biopsy for patients with acute allograft dysfunction (20% increase of creatinine) without current evident causes of graft dysfunction. The maximum study duration for a subject, between inclusion and follow-up visits, will be 12 months and the estimated length of time needed to complete the entire study (from enrolment of the first subject to completion of the last subject) 18 months.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Privigen (Human normal immunoglobulin G (IgG > 98 % purity))	Privigen (CSL Behring AG, Bern, Switzerland) 10% liquid human IgG for intravenous administration, 2 g/kg, given as 2 g/kg for 2 days/month for 6 months (maximum dose: 80 g/day). Privigen will be provided in vials containing 10 g IgG in 100 mL.

Timeline

• Start date: 2016-02-05
• Primary completion: 2018-03-09
• Completion: 2019-05-09
• First posted: 2015-03-02
• Last updated: 2021-03-09

Locations

1 site across 1 country: France