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Effect of Privigen Against Graft Loss

NCT02374736 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-03-09

No results posted yet for this study

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.

Conditions

  • Kidney Transplantation

Interventions

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.

Sponsors & Collaborators

  • CSL Behring

    collaborator INDUSTRY

  • Association ASLUMARE

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Denis GLOTZ, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-05
Primary Completion
2018-03-09
Completion
2019-05-09

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02374736 on ClinicalTrials.gov