Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01550445

Steroid Withdrawal Immunosuppression After Renal Transplantation

Disorder Related to Renal Transplantation Clinical Trial

Official title:
Prospective Controlled Protocol for 3 Months Steroid Withdrawal With Tacrolimus, Basiliximab, and Mycophenolate Mofetil in Renal Transplant Recipients

Clinical Trial Summary

The investigators analyze the clinical outcome of steroid withdrawal protocol starting at 3 months after kidney transplantation using tacrolimus, Mycophenolate Mofetil (MMF), and basiliximab. This study is an open-label, prospective, controlled clinical trial in a single center. Those patients who fulfill the entry criteria could enter in this prospective controlled trial of steroid withdrawal three months after transplantation.

Clinical Trial Description

Those patients who fulfill the entry criteria enter in this prospective controlled trial of steroid withdrawal starting at three months after transplantation. The entry criteria include 1) no episode of clinically treated nor biopsy confirmed acute rejection up to entry; 2) serum creatinine level equal to or less than 2 mg/mL on three separate measurements; 3) no proteinuria (urine protein less than 1000 mg/24 hours; 4) tacrolimus trough level > 5 ng/ml without signs of nephrotoxicity; 5) agreement to follow the study protocol.

For the patients who enter into the protocol, prednisolone would be slowly withdrawn by 2.5 mg in every two weeks until 8 weeks after entering the protocol (5 months post-transplantation). The patients visit every week, and they are closely monitored with symptoms and signs, blood cell count, chemistry, and urinalysis. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Disorder Related to Renal Transplantation
Clinical Trial Details
NCT number NCT01550445
Study type Interventional
Source Ajou University School of Medicine
Contact chang-kwon Oh, M.D
Phone 82-10-9165-7281
Email ohck@ajou.ac.kr
Status Recruiting
Phase Phase 4
Start date May 2008
Completion date July 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT02581436 - Testing Immunosuppression Threshold in Renal Allografts To Extend eGFR N/A
Terminated NCT01561404 - Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise Phase 4
Recruiting NCT02849899 - Prevention of Diabetes After Transplantation by Vildagliptin in the Early Post-transplant Period Phase 3
Not yet recruiting NCT01289301 - Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant Phase 4
Completed NCT00905957 - Transversus Abdominis Plane Block For Renal Transplant Recipients N/A
Active, not recruiting NCT02843867 - Orientation of the Lymphocyte Response to the Occurrence of Atherosclerotic Complications After Kidney Transplantation
Active, not recruiting NCT02751099 - Bone and Cardiovascular Disease After Kidney Transplant
Completed NCT01744067 - The Effects of Omega-3 Fatty Acids in Renal Transplantation Phase 4
Completed NCT01646099 - Sun Protection of Kidney Transplant Recipients N/A
Active, not recruiting NCT03935958 - Curcumin in Kidney Transplant Recipients N/A
Recruiting NCT02513602 - Osseointegrated Dental Implants in Kidney Transplanted Patients N/A
Completed NCT01844713 - Evaluation of Sun Protection Education for Kidney Transplant Recipients N/A
Completed NCT02540395 - Prospective Donor Specific T Response Measurment for IS Minimization in de Novo Renal Transplantation N/A
Completed NCT01195194 - Selection of Immunosuppression in Kidney Transplant Recipients Depending on Pre-transplant Donor-specific T-cell Reactivity. Phase 4
Completed NCT00724022 - Phase IV Study to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation Phase 4
Terminated NCT00167661 - Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation Phase 1/Phase 2
Completed NCT03968588 - Standard- Versus Reduced-dose Tacrolimus Combined With Generic Mycophenolate Mofetil in De Novo Renal Transplantation Phase 4
Recruiting NCT02515643 - Contribution of Renal Function to Endothelial Dysfunction in Living Kidney Donors and Transplant Recipients N/A
Completed NCT00455013 - A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation Phase 2
Recruiting NCT02843763 - Study of Specific CD4 Tumors Th1 Responses in Renal Transplant After Occurrence of Cancer N/A