Elsevier

Transplantation Proceedings

Volume 42, Issue 9, November 2010, Pages 3503-3506
Transplantation Proceedings

Renal transplantation
Outcome
Randomized Trial of Thymoglobulin Versus Alemtuzumab (with Lower Dose Maintenance Immunosuppression) Versus Daclizumab in Living Donor Renal Transplantation

https://doi.org/10.1016/j.transproceed.2010.08.045Get rights and content

Abstract

Background

We performed a randomized trial evaluating Alemtuzumab, a humanized anti-CD52 monoclonal antibody, in living donor (LD) kidney transplantation.

Methods

Thirty-eight LD first renal transplant recipients were randomized into three single-agent antibody induction groups: thymoglobulin (group A); alemtuzumab (group B); and daclizumab (group C). In groups A and C, target tacrolimus trough levels were 6 to 8 ng/mL, with 1 gm mycophenolate mofetil (MMF) administered twice daily, and maintenance methylprednisolone. In group B, the target tacrolimus trough level was 4 to 6 ng/mL, with 500 mg MMF administered twice daily, without methylprednisolone.

Results

With 29/38 patients now followed beyond 36 months posttransplantation, we observed no graft failures and only one death with a functioning graft (in group B). Acute rejection episodes were low: 0/13, 1/13, and 1/12 patients in groups A, B, and C. Biopsy-proven chronic allograft injury was higher among group B (3/13) versus groups A (0/13) or C (0/12; P = .01). Poorer renal function was observed in group B; the mean calculated creatinine clearance at 3 months posttransplantation was significantly poorer: 63.3 ± 3.0 versus 85.4 ± 7.2 and 82.2 ± 8.2 in groups A and C (P = .01). No differences in the incidence of adverse events were observed.

Section snippets

Methods and Patients

Between September 2002 and October 2006, we prospectively randomized 38 recipients of LD first kidney transplant recipients of 16 to 66 years of age, using an open label design immediately before transplantation. The institutional review board approved the protocol, and patients provided written informed consent prior to enrollment. Exclusion criteria were similar to other prospective randomized trials performed at our center.11, 12, 13 Group A (n = 13) received thymoglobulin (1 mg/kg/d) for

Results

The distributions of baseline demographic features are reported in Table 1. There were no significant differences among the three groups regarding age, presence of type 2 diabetes, race/ethnicity, gender, donor age, or total human leukocyte antigen (HLA) mismatches. The percentages of African-Americans and Hispanics combined were 46%, 54%, and 50% in groups A, B, and C, respectively. Note that 35/38 patients received a living related donor kidney; the three patients who received a living

Discussion

In September 2002, we embarked on this three-arm prospective, open label, randomized trial of single-agent induction therapy among first LD kidney transplant recipients with the following goals: (1) to determine the overall safety and efficacy of administering alemtuzumab versus thymoglobulin or daclizumab, and (2) to assess in a long-term study the safety of lower CI concentrations and steroid avoidance in the alemtuzumab arm. Early results of a similarly conducted randomized trial among 90

References (15)

There are more references available in the full text version of this article.

Cited by (34)

  • Anesthesia and Perioperative Care in Reconstructive Transplantation

    2017, Anesthesiology Clinics
    Citation Excerpt :

    Premedication with steroids (bolus methylprednisolone), along with diphenhydramine and acetaminophen, may be helpful to minimize risk of CRS. In contrast to alemtuzumab and thymoglobulin, basiliximab and daclizumab have a superior safety profile (similar to placebo) and do not cause CRS.34,40–42 However, rare hypersensitive reactions can occur with these agents, resulting in intraoperative or perioperative hypotension, tachycardia, cardiac failure, bronchospasm, pulmonary edema, and respiratory failure.43

  • Randomized trial of rATg/Daclizumab vs. rATg/Alemtuzumab as dual induction therapy in renal transplantation: Results at 8 years of follow-up

    2017, Transplant Immunology
    Citation Excerpt :

    In both groups, tacrolimus was initiated at 0.1 mg/kg twice daily once renal function improved (serum creatinine concentration (Cr) < 4 mg/dl absent dialysis), with a target (12 h) trough level of 4–8 ng/ml. Target enteric-coated mycophenolate sodium(EC-MPS) dosing was 720 mg vs. 360 mg twice daily for Groups I and II, respectively; one-half of standard daily EC-MPS dosing was targeted in Group II in order to avoid severe leukopenia previously seen with C1H [5–8]. Any withholding of EC-MPS for at least 2 weeks was documented along with reasons for withholding.

View all citing articles on Scopus
View full text