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A Comparison of Two Types of Rabbit Antithymocyte Globulin Induction Therapy in Immunological High-Risk Kidney Recipients: A Prospective Randomized Control Study.
Burkhalter, F; Schaub, S; Bucher, Ch; Gürke, L; Bachmann, A; Hopfer, H; Dickenmann, M; Steiger, J; Binet, I.
Affiliation
  • Burkhalter F; Clinic for Transplant Immunology and Nephrology, University Hospital Basel, Basel, Switzerland.
  • Schaub S; Clinic for Transplant Immunology and Nephrology, University Hospital Basel, Basel, Switzerland.
  • Bucher C; Nephrology and Transplantation Medicine, Kantonsspital St Gallen, St Gallen, Switzerland.
  • Gürke L; Department of Vascular and Transplant Surgery, University Hospital Basel, Basel, Switzerland.
  • Bachmann A; Department of Urology, Basel University Hospital, Basel, Switzerland.
  • Hopfer H; Institute for Pathology, University Hospital Basel, Basel, Switzerland.
  • Dickenmann M; Clinic for Transplant Immunology and Nephrology, University Hospital Basel, Basel, Switzerland.
  • Steiger J; Clinic for Transplant Immunology and Nephrology, University Hospital Basel, Basel, Switzerland.
  • Binet I; Nephrology and Transplantation Medicine, Kantonsspital St Gallen, St Gallen, Switzerland.
PLoS One ; 11(11): e0165233, 2016.
Article in En | MEDLINE | ID: mdl-27855166
ABSTRACT

BACKGROUND:

Induction treatment with rabbit polyclonal antithymocyte globulins (ATGs) is frequent used in kidney transplant recipients with donorspecific HLA antibodies and shows acceptable outcomes. The two commonly used ATGs, Thymoglobulin and ATG-F have slightly different antigen profile and antibody concentrations. The two compounds have never been directly compared in a prospective trial in immunological high-risk recipients. Therefore we performed a prospective randomized controlled study comparing the two compounds in immunological high-risk kidney recipients in terms of safety and efficacy.

METHODS:

Immunological high-risk kidney recipients, defined as the presence of HLA DSA but negative CDC-B and T-cell crossmatches were randomized 11 to receive ATG-F or Thymoglobulin. Maintenance immunosuppressive therapy consisted of tacrolimus, mycophenolate mofetil and steroids.

RESULTS:

The per-protocol analysis included 35 patients. There was no immediate infusion reaction observed with both compounds. No PTLD or malignancy occurred during the follow-up in both groups. The incidence of viral and bacterial infections was similar in both groups (p = 0.62). The cumulative incidence of clinical and subclinical antibody mediated allograft rejection as well as T-cell mediated allograft rejection during the first year between ATG-F and Thymoglobulin was similar (35% versus 19%; p = 0.30 and 11% versus 18%; 0.54 respectively). The two-year graft function was similar with a median eGFR of 56 ml/min/1.73m2 (range 21-128) (ATG-F-group) and 51 ml/min/1.73m2 (range 22-132) (Thymo-group) (p = 0.69).

CONCLUSION:

We found no significant differences between the compared study drugs for induction treatment in immunological high-risk patients regarding safety and efficacy during follow-up with good allograft function at 2 years after transplantation.
Subject(s)

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Kidney Transplantation / Transplant Recipients / Graft Rejection / Immunosuppressive Agents / Antilymphocyte Serum Type of study: Clinical_trials / Diagnostic_studies / Etiology_studies / Guideline / Risk_factors_studies Limits: Adult / Aged / Animals / Female / Humans / Male / Middle aged Language: En Journal: PLoS One Journal subject: CIENCIA / MEDICINA Year: 2016 Document type: Article Affiliation country: Switzerland

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Kidney Transplantation / Transplant Recipients / Graft Rejection / Immunosuppressive Agents / Antilymphocyte Serum Type of study: Clinical_trials / Diagnostic_studies / Etiology_studies / Guideline / Risk_factors_studies Limits: Adult / Aged / Animals / Female / Humans / Male / Middle aged Language: En Journal: PLoS One Journal subject: CIENCIA / MEDICINA Year: 2016 Document type: Article Affiliation country: Switzerland