Clinical Trials Logo

Clinical Trial Summary

This study aims to prove similar efficacy of PE/rATG (intervention) and PE/rATG/IVIG (centre standard of care) induction regimens to prevent biopsy proven antibody-mediated changes and TCMR as composite endpoint within 12 months after HLA incompatible kidney transplantation.


Clinical Trial Description

There have been no published clinical studies evaluating rATG/IVIG induction protocol in comparison with rATG alone in defined cohort of HLA incompatible kidney transplant recipients. Prescribing IVIG in management of prevention of transplant rejection is considered off-label use, however IVIG remains part of induction protocols in many transplant centres. IVIG therapy is demanding due to high cost and limited resources of these human origin products. Trial participants will be end-stage renal disease (ESRD) patients listed for deceased donor / living donor kidney transplantation with anti HLA antibody screening performed within 12 months before transplantation and with last DSA 1 000 - 5 000 Mean Fluorescence Intensity (MFI) and negative CDC (Complement-dependent cytotoxicity crossmatch test) prior to transplantation. Participants will be randomized into one of the treatment groups (PE/PP(Plasmapheresis) + rATG + IVIG, PE/PP + rATG) and as a primary outcome a composite endpoint defined as occurrence of antibody- or T-cell mediated rejection within 12 months after transplantation will be evaluated. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04302805
Study type Interventional
Source Institute for Clinical and Experimental Medicine
Contact Ondrej Viklicky, Prof.
Phone +420 261364110
Email ondrej.viklicky@ikem.cz
Status Recruiting
Phase Phase 3
Start date July 27, 2020
Completion date April 15, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04910867 - APOL1 Genetic Testing Program for Living Donors N/A
Completed NCT02723591 - To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients Phase 4
Completed NCT05945511 - Silent Gallbladder Stone in Kidney Transplantation Recipients: Should it be Treated?
Completed NCT02234349 - Bile Acids and Incretins in Pancreas Kidney Transplant Patients N/A
Completed NCT04496401 - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus Phase 4
Recruiting NCT05917795 - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates N/A
Not yet recruiting NCT05934383 - Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension N/A
Withdrawn NCT04936971 - Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response Phase 4
Not yet recruiting NCT04540640 - Oxygenated Machine Preservation in Kidney Transplantation N/A
Not yet recruiting NCT03090828 - Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease N/A
Recruiting NCT02908139 - Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients N/A
Terminated NCT02417870 - Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation Phase 1/Phase 2
Completed NCT02560558 - Bela 8 Week Dosing Phase 4
Recruiting NCT02154815 - Pre-emptive Kidney Transplantation Quality of Life N/A
Completed NCT02235571 - iChoose Decision Kidney Aid for End-Stage Renal Disease Patients N/A
Enrolling by invitation NCT01905514 - ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients N/A
Completed NCT02147210 - Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1 N/A
Recruiting NCT01699360 - The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients Phase 4
Completed NCT01672957 - ORANGE Study: An Observational Study on Renal Function in Kidney Transplant Patients on Immunosuppressive Therapy Containing CellCept (Mycophenolate Mofetil) N/A
Terminated NCT01436305 - Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation Phase 2