Logo Annals of Transplantation Logo Annals of Transplantation Logo Annals of Transplantation

06 December 2003

Freedom from rejection and stable kidney function are excellent criteria for steroid withdrawal in tacrolimus-treated kidney transplant recipients.

Z Włodarczyk, J J Wałaszewski, F F Perner, S S Vitko, M M Ostrowski, P P Bachleda, F F Kokot, M M Klinger, P P Szenohradsky, P P Studenik, P P Navratil, L L Asztalos, B B Rutkowski, K Kalmar KK Nagy, D D Hickey

Ann Transplant 2002; 7(3): 28-31 :: ID: 5544

Abstract

OBJECTIVES: This prospective, randomized, multicentre study investigated the efficacy and safety of two tacrolimus-based regimens and their potential to withdraw steroids. METHODS: In total 489 patients were randomised to receive either tacrolimus and MMF (n = 243) or tacrolimus and azathioprine (n = 246) concomitantly with steroids in both treatment groups. The initial oral dose of tacrolimus was 0.2 mg/kg/day, MMF dose was 1 g/day, azathioprine was administered at 1-2 mg/day. Steroids were tapered from 20 mg/day to 5 mg/day. From month 3 onwards, steroids were withdrawn in patients who were free from steroid-resistant rejection and who had serum creatinine concentrations < 160 mumol/L. Study duration was 6 months. RESULTS: Patient survival at month 6 was 98.3% (Tac/MMF/S) and 98.4% (Tac/Aza/S), graft survival at 6 month was 95.0% (Tac/MMF/S) and 93.5% (Tac/Aza/S). The 6-month incidences of biopsy-proven acute rejection were 18.9% (Tac/MMF/S) compared with 26.8% (Tac/Aza/S), p = 0.038. The 6-month incidences of steroid-resistant acute rejection were 2.1% (Tac/MMF/S) and 4.9% (Tac/Aza/S), p = ns. At the end of month 3, steroid withdrawal was performed in 60.5% (Tac/MMF/S) and 48.8% (Tac/Aza/S) of patients, p < 0.01. During months 4-6, 2.7% of patients in the Tac/MMF group had a biopsy-confirmed acute rejection compared with 0.8% of patients in the Tac/Aza group. In patients who continued to receive steroids, the incidences of biopsy-proven acute rejections during months 4-6 were 3.5% (Tac/MMF/S) and 7.1% (Tac/Aza/S). At study end, the steroid-free patients had an excellent kidney function, the median serum creatinine concentration was 119.5 mumol/L (Tac/MMF) and 115.1 mumol/L (Tac/Aza); the median serum creatinine of the total study group was 130.5 mumol/L (Tac/MMF/S) and 132.8 mumol/L (Tac/Aza/S). CONCLUSION: Both tacrolimus regimens are efficacious and safe. The combination of Tacrolimus and MMF achieved a lower rejection rate and permitted a higher proportion of steroid-free patients. The overall incidence of acute rejection was low and kidney function was good.

Keywords:

0 Comments

In Press

11 Jan 2022 : Original article  

Efficacy of Nitric Oxide-Releasing Nanofibers in Reducing Renal Ischemia-Reperfusion Injury in a Rat Model

Ann Transplant In Press; DOI: 10.12659/AOT.934800  

11 Jan 2022 : Original article  

Effects of Substance P for Liver Regeneration in Rat Hepatectomy Models: A Preliminary Experimental Animal ...

Ann Transplant In Press; DOI: 10.12659/AOT.934801  

Most Viewed Current Articles

29 Dec 2021 : Original article  

Efficacy and Safety of Tacrolimus-Based Maintenance Regimens in De Novo Kidney Transplant Recipients: A Sys...

DOI :10.12659/AOT.933588

Ann Transplant 2021; 26:e933588

22 Dec 2021 : Original article  

Comparison of Coronary Artery Calcium Scoring with Dobutamine Stress Echo for Detection of Coronary Artery ...

DOI :10.12659/AOT.934163

Ann Transplant 2021; 26:e934163

01 Dec 2021 : Original article  

Solid-Phase C1q/C3d Fixing Readouts Correlate with High Median Fluorescence Intensity (MFI) De Novo Donor-S...

DOI :10.12659/AOT.934175

Ann Transplant 2021; 26:e934175

23 Nov 2021 : Original article  

The Future Direction of the Organ Donation System After Legislation of the Life-Sustaining Treatment Decisi...

DOI :10.12659/AOT.934345

Ann Transplant 2021; 26:e934345

Your Privacy

We use cookies to ensure the functionality of our website, to personalize content and advertising, to provide social media features, and to analyze our traffic. If you allow us to do so, we also inform our social media, advertising and analysis partners about your use of our website, You can decise for yourself which categories you you want to deny or allow. Please note that based on your settings not all functionalities of the site are available. View our privacy policy.

Annals of Transplantation eISSN: 2329-0358
Annals of Transplantation eISSN: 2329-0358