A prospective, randomized, multicenter study evaluating early corticosteroid withdrawal with Thymoglobulin<sup>®</sup> in living‐donor kidney transplantation

Woodle, E. Steve; Peddi, V. Ram; Tomlanovich, S.; Mulgaonkar, Shamkant; Kuo, Paul C.

doi:10.1111/j.1399-0012.2009.01127.x

Cited by 67 publications

(72 citation statements)

References 11 publications

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“…Compared with conventional steroid use, when TAC and MPA were used, the no-steroid arm was not associated with higher acute rejection (RR, 1.06; 95% CI, 0.79 to 1.42), death (RR, 1.09; 95% CI, 0.50 to 2.37), and graft loss (RR, 1.29; 95% CI, 0.71 to 2.34). Similar findings were observed in a prospective, randomized multicenter trial (Thymoglobulin in Renal Transplantation for Induction and Minimization of Steroids study, n=153), which evaluated early corticosteroid withdrawal in LRT recipients who received r-ATG induction and TAC/MPA maintenance (8). In another steroid withdrawal randomized controlled trial (TAC/MPA maintenance regimen), Hanaway et al stratified recipients based on their immunologic risk; low-risk patients (n=335) were randomized to alemtuzumab or basiliximab, whereas high-risk patients (n=139) received alemtuzumab or r-ATG (34).…”

Section: Steroid Avoidancesupporting

confidence: 63%

“…Prospective randomized multicenter studies and retrospective registry analysis demonstrate that no-induction therapy can achieve acceptable acute rejection rates (10%-20% at 1 year after transplant), with allograft and patient survival similar to other induction modalities in living donor renal transplantation (LRT) (7)(8)(9)(10). However, the current Kidney Disease Improving Global Outcomes (KDIGO) Transplant Work Group guidelines recommend IL2-RA as a first-line induction agent in all types of donor-recipient profiles to reduce risk of acute rejection and allograft loss.…”

Section: Introductionmentioning

confidence: 99%

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Induction Therapies in Live Donor Kidney Transplantation on Tacrolimus and Mycophenolate With or Without Steroid Maintenance

Tanrıöver¹,

Zhang²,

MacConmara

et al. 2015

Clinical Journal of the American Society of Nephrology

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Background and objectives Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first line agent in living donor renal transplantation (LRT). However, use of IL2-RA remains controversial in LRT with tacrolimus (TAC)/mycophenolic acid (MPA) with or without steroids.Design, setting, participants, & measurements The Organ Procurement and Transplantation Network registry was studied for patients receiving LRT from 2000 to 2012 maintained on TAC/MPA at discharge (n536,153) to compare effectiveness of IL2-RA to other induction options. The cohort was initially divided into two groups based on use of maintenance steroid at time of hospital discharge: steroid (n525,996) versus no-steroid (n510,157). Each group was further stratified into three categories according to commonly used antibody induction approach: IL2-RA, rabbit anti-thymocyte globulin (r-ATG), and no-induction in the steroid group versus IL2-RA, r-ATG and alemtuzumab in the no-steroid group. The main outcomes were the risk of acute rejection at 1 year and overall allograft failure (graft failure or death) post-transplantation through the end of follow-up. Propensity score-weighted regression analysis was used to minimize selection bias due to non-random assignment of induction therapies.Results Multivariable logistic and Cox analysis adjusted for propensity score showed that outcomes in the steroid group were similar between no-induction (odds ratio [OR], 0.96; 95% confidence interval [95% CI], 0.86 to 1.08 for acute rejection; and hazard ratio [HR], 0.99; 95% CI, 0.90 to 1.08 for overall allograft failure) and IL2-RA categories. In the no-steroid group, odds of acute rejection with r-ATG (OR, 0.73; 95% CI, 0.59 to 0.90) and alemtuzumab (OR, 0.53; 95% CI, 0.42 to 0.67) were lower; however, overall allograft failure risk was higher with alemtuzumab (HR, 1.27; 95% CI, 1.03 to 1.56) but not with r-ATG (HR, 1.19; 95% CI, 0.97 to 1.45), compared with IL2-RA induction.Conclusions Compared with no-induction therapy, IL2-RA induction was not associated with better outcomes when TAC/MPA/steroids were used in LRT recipients. r-ATG appears to be an acceptable and possibly the preferred induction alternative for IL2-RA in steroid-avoidance protocols.

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Section: Steroid Avoidancesupporting

confidence: 63%

Section: Introductionmentioning

confidence: 99%

Induction Therapies in Live Donor Kidney Transplantation on Tacrolimus and Mycophenolate With or Without Steroid Maintenance

Tanrıöver¹,

Zhang²,

MacConmara

et al. 2015

Clinical Journal of the American Society of Nephrology

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“…In the era of TAC/MPA maintenance regimens with or without steroids, controversy exists with respect to the added benefit of IL2-RA induction therapy on outcomes of renal transplantation. In fact, there are recent data that support that no induction therapy could achieve acceptable acute rejection rates (#20% at 1 year after transplantation), with similar allograft and patient survival compared with IL2-RA induction in the setting of the TAC/MPA maintenance regimen (8)(9)(10)(11)(12).…”

Section: Introductionmentioning

confidence: 99%

Acute Rejection Rates and Graft Outcomes According to Induction Regimen among Recipients of Kidneys from Deceased Donors Treated with Tacrolimus and Mycophenolate

Tanrıöver

Jaikaransingh

MacConmara³

et al. 2016

CJASN

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Background and objectives IL-2 receptor antagonist (IL2-RA) is recommended as a first-line agent for induction therapy in renal transplantation. However, this remains controversial in deceased donor renal transplantation (DDRT) maintained on tacrolimus (TAC)/mycophenolic acid (MPA) with or without steroids.Design, setting, participants, & measurements We studied the United Network for Organ Sharing Registry for patients receiving DDRT from 2000 to 2012 maintained on TAC/MPA at transplantation hospital discharge (n=74,627) to compare outcomes of IL2-RA and other induction agents. We initially divided the cohort into two groups on the basis of steroid use at the time of discharge: steroid (n=59,010) versus no steroid (n=15,617). Each group was stratified into induction categories: IL2-RA, rabbit antithymocyte globulin (r-ATG), alemtuzumab, and no induction. The main outcomes were incidence of acute rejection within the first year and overall graft failure (defined as graft failure and/or death) post-transplantation. Propensity score (PS), specifically inverse probability of treatment weight, analysis was used to minimize selection bias caused by nonrandom assignment of induction therapies.Results Median (25th, 75th percentiles) follow-up times were 3.9 (1.1, 5.9) and 3.2 (1.1, 4.9) years for steroid and no steroid groups, respectively. Acute rejection within the first year and overall graft failure within 5 years of transplantation were more common in the no induction category (13.3%; P,0.001 and 28%; P=0.01, respectively) in the steroid group and the IL2-RA category (11.1%; P=0.16 and 27.4%; P,0.001, respectively) in the no steroid group. Compared with IL2-RA, PS-weighted and covariate-adjusted multivariable logistic and Cox analyses showed that outcomes in the steroid group were similar among induction categories, except that acute rejection was significantly lower with r-ATG (odds ratio [OR], 0.68; 95% confidence interval [95% CI], 0.62 to 0.74). In the no steroid group, compared with IL2-RA, odds of acute rejection with r-ATG (OR, 0.80; 95% CI, 0.60 to 1.00) and alemtuzumab (OR, 0.68; 95% CI, 0.53 to 0.88) were lower, and r-ATG was associated with better graft survival (hazard ratio, 0.86; 95% CI, 0.75 to 0.99).Conclusions In DDRT, compared with IL2-RA induction, no induction was associated with similar outcomes when TAC/MPA/steroids were used. r-ATG seems to offer better graft survival over IL2-RA in steroid avoidance protocols.

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“…Several multicenter randomized control trials, that directly compare the risks and benefits of rapid withdrawal or complete avoidance of steroids with regimens using maintenance steroids, in adult patients after renal transplantation have been published [10][11][12][13][14][15]. Most of these trials have demonstrated no increase in the incidence of acute rejection when steroids are minimized after transplantation [14].…”

Section: Introductionmentioning

confidence: 99%

“…Most of these trials have demonstrated no increase in the incidence of acute rejection when steroids are minimized after transplantation [14]. Data on metabolic and cardiovascular benefits of steroid minimization are less robust although the studies do show a lower need for antihyperglycemic and lipid-lowering agents, lesser weight gain and better triglyceride levels with steroid avoidance [13,15].…”

Section: Introductionmentioning

confidence: 99%

Steroid Minimization in Pediatric Renal Transplantation

Lau¹,

Butani

2012

J Nephrol Therapeutic

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A prospective, randomized, multicenter study evaluating early corticosteroid withdrawal with Thymoglobulin^® in living‐donor kidney transplantation

Abstract: rATG with tacrolimus and MMF therapy may allow early elimination of corticosteroids, is associated with trends toward lower lipid levels, less weight gain, and a safety profile comparable to CCST therapy.

Cited by 67 publications

References 11 publications

Induction Therapies in Live Donor Kidney Transplantation on Tacrolimus and Mycophenolate With or Without Steroid Maintenance

Induction Therapies in Live Donor Kidney Transplantation on Tacrolimus and Mycophenolate With or Without Steroid Maintenance

Acute Rejection Rates and Graft Outcomes According to Induction Regimen among Recipients of Kidneys from Deceased Donors Treated with Tacrolimus and Mycophenolate

Steroid Minimization in Pediatric Renal Transplantation

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A prospective, randomized, multicenter study evaluating early corticosteroid withdrawal with Thymoglobulin® in living‐donor kidney transplantation

Abstract: rATG with tacrolimus and MMF therapy may allow early elimination of corticosteroids, is associated with trends toward lower lipid levels, less weight gain, and a safety profile comparable to CCST therapy.

Cited by 67 publications

References 11 publications

Induction Therapies in Live Donor Kidney Transplantation on Tacrolimus and Mycophenolate With or Without Steroid Maintenance

Induction Therapies in Live Donor Kidney Transplantation on Tacrolimus and Mycophenolate With or Without Steroid Maintenance

Acute Rejection Rates and Graft Outcomes According to Induction Regimen among Recipients of Kidneys from Deceased Donors Treated with Tacrolimus and Mycophenolate

Steroid Minimization in Pediatric Renal Transplantation

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A prospective, randomized, multicenter study evaluating early corticosteroid withdrawal with Thymoglobulin^® in living‐donor kidney transplantation