Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-11 @ 3:40 PM
Study NCT ID:
NCT02711202
Status:
COMPLETED
Last Update Posted:
2025-06-04
First Post:
2016-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sequential Targeting of Cluster of Differentiation 52 (CD52) and Tumor Necrosis Factor (TNF) Allows Early Minimization Therapy in Kidney Transplantation
Sponsor:
Institute for Clinical and Experimental Medicine
Organization:
Study Overview
Official Title:
A Pilot, Open Single Centre, Prospective, Parallel Trail to Evaluate the Efficacy and Safety of Immunosuppressive Regimen Without Calcineurin Inhibitors and Steroids After Induction of Anti-CD52 and Anti-TNF-α Monoclonal Antibodies in Kidney Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to evaluate the efficacy of new immunosuppressive protocol based on two applications of anti-CD52 MabCampath (Alemtuzumab) a single dose of anti-TNF-α Remicade (infliximab) monoclonal antibodies in the early posttransplant period followed by either monotherapy based on tacrolimus or sirolimus.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: