A Randomized, Double-Blinded Comparison of Thymoglobulin Versus Atgam for Induction Immunosuppressive Therapy in Adult Renal Transplant Recipients1,2

Brennan, Daniel C.; Flavin, Karen; Lowell, Jeffrey A.; Howard, Todd K.; Shenoy, Surendra; Burgess, S. E. P.; Dolan, Sara; Kano, J.M; Mahon, M; Schnitzler, Mark A.; Woodward, Robert S.; Irish, William; Singer, Gary G.

doi:10.1097/00007890-199904150-00013

Cited by 347 publications

(230 citation statements)

References 32 publications

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“…28,13 Bacterial pneumonia was more frequent in the alemtuzumab group (33% vs 0%, p<0.029), as also reported in the study by Vathsala et als. 28 Cytomegalovirus infection was equally present in both groups (22% vs. 39%, p= ns), but with a higher incidence than that reported in another series (6.5% vs. 3.3%) 29 , possibly due to the non systematic use of prophylaxis at our center.…”

Section: Discussionsupporting

confidence: 81%

“…The prophylactic treatment has been associated with reduced incidences of CMV infection in other series using induction therapy with alemtuzumab (5%) 28 or thymoglobulin (10.4%). 13 No lymphoproliferative disease occurred during followup.…”

Section: Discussionmentioning

confidence: 95%

“…That pharmacodynamic effect occurs in a dose-dependent way through mechanisms involving antibody-mediated cytotoxicity, cell-mediated cytotoxicity, and apoptosis, limiting tissue migration during organ reperfusion or acute rejection episodes. 13,14 In some studies, the use of thymoglobulin has been associated with a lower incidence and duration of delayed graft function 4 , lower incidence of acute rejection, and better graft survival. 14 However, thymoglobulin has been approved and registered only for the treatment of acute rejection.…”

Section: Definitionsmentioning

confidence: 99%

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Terapia de indução com alentuzumabe em receptores de transplante renal

Sampaio¹,

Freitas²,

Galante³

et al. 2010

J. Bras. Nefrol.

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Introduction: Induction therapy has been used in sensitized patients, re-transplants, and in patients who have high risk to delayed graft function (DGF) after renal transplantation. Methods: Retrospective study with aim to compare transplant endpoints between recipients of deceased donors which have received induction with alemtuzumab (n = 9) versus thymoglobulin (n = 18). Patients were matched for age, duration of dialysis treatment and cold ischemia time. Results: There were no differences at demographic characteristics. All patients received kidney grafts from deceased donors and 67% of these donors met the expanded criteria. The incidence of DFG was similar in alemtuzumab and thymoglobulin groups, 55% and 56%. At 12 months, rates of rejection free survival (67% versus 89%, p = 0,13), graft survival (62,5% versus 76,6%; p = 0,73), graft with death censored (62,5% versus 76,6%; p = 0,82) and patient survival (83,3% versus 81,2%; p = 0,63) were similar between the two groups. Viral infections and renal function were similar between groups. At the end of the first month, alemtuzumab patients displayed a fewer lymphocyte number (135 ± 78 versus 263 ± 112 N/mm 3 , p < 0,05) followed by a more rapid recovery after 3 months (day 90: 683 ± 367 versus 282 ± 72 N/mm 3 ; p < 0,05). Cost associated with alemtuzumab and thymoglobulin inductions therapies were R$ 1,388.00 and R$ 7,398.00. Conclusion: In this cohort of patients, alemtuzumab induction showed efficacy and safety comparable to thymoglobulin but with significant cost reduction.

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Section: Discussionsupporting

confidence: 81%

Section: Discussionmentioning

confidence: 95%

Section: Definitionsmentioning

confidence: 99%

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Terapia de indução com alentuzumabe em receptores de transplante renal

Sampaio¹,

Freitas²,

Galante³

et al. 2010

J. Bras. Nefrol.

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“…In a blinded single‐center trial that compared induction with rabbit versus equine DD‐ATG, there was less rejection and superior graft survival in the rATG group after 10 years 12. Recent publications suggest that SD‐rATG, compared with basiliximab or more‐conventional divided‐dose administration of the same rATG amount, may reduce the frequency of delayed graft function (DGF) or improve recovery of renal function in recipients of deceased‐donor kidneys 1, 13, 14.…”

Section: Introductionmentioning

confidence: 99%

“…fevers, hypotension, etc.) 7, 12, 15. We believed that the difficulty of maintaining blinding could be overcome and hypothesized that SD‐rATG induction is not inferior to DD‐rATG induction.…”

Section: Introductionmentioning

confidence: 99%

A Double-Blind, Double-Dummy, Flexible-Design Randomized Multicenter Trial: Early Safety of Single- Versus Divided-Dose Rabbit Anti-Thymocyte Globulin Induction in Renal Transplantation

Stevens

Wrenshall

Miles

et al. 2016

American Journal of Transplantation

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A previous nonblinded, randomized, single‐center renal transplantation trial of single‐dose rabbit anti‐thymocyte globulin induction (SD‐rATG) showed improved efficacy compared with conventional divided‐dose (DD‐rATG) administration. The present multicenter, double‐blind/double‐dummy STAT trial (Single dose vs. Traditional Administration of Thymoglobulin) evaluated SD‐rATG versus DD‐rATG induction for noninferiority in early (7‐day) safety and tolerability. Ninety‐five patients (randomized 1:1) received 6 mg/kg SD‐rATG or 1.5 mg/kg/dose DD‐rATG, with tacrolimus‐mycophenolate maintenance immunosuppression. The primary end point was a composite of fever, hypoxia, hypotension, cardiac complications, and delayed graft function. Secondary end points included 12‐month patient survival, graft survival, and rejection. Target enrollment was 165 patients with an interim analysis scheduled after 80 patients. Interim analysis showed primary end point noninferiority of SD‐rATG induction (p = 0.6), and a conditional probability of <1.73% of continued enrollment producing a significant difference (futility analysis), leading to early trial termination. Final analysis (95 patients) showed no differences in occurrence of primary end point events (p = 0.58) or patients with no, one, or more than one event (p = 0.81), or rejection, graft, or patient survival (p = 0.78, 0.47, and 0.35, respectively). In this rigorously blinded trial in adult renal transplantation, we have shown SD‐rATG induction to be noninferior to DD‐rATG induction in early tolerability and equivalent in 12‐month safety. (Clinical Trials.gov #NCT00906204.)

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