A randomized trial with two anti‐CMV hyperimmune globulins in the prevention of CMV disease in CMV‐negative renal transplant patients

Cytomegalovirus (CMV) causes marked morbidity in renal transplant patients which may be prevented by passive immunization. We studied the effect of two different hyperimmune globulins in the prevention of CMV disease in seronegative patients receiving renal transplants from seropositive donors. Thirty patients were randomized to receive either anti‐CMV i.v. Ig (pH 4‐pepsin treated), or CytotectR (beta‐propiolactone treated) 1.5 ml/kg on day 1, 1.0 mg/kg on d 14 and 28, 0.5 ml/kg on d 42, 56, 84 and 112 post‐transplantation. As controls, 15 patients transplanted without CMV prophylaxis immediately before (12 patients) and after (3 patients) the randomization period, were included. All patients and controls received same basic immunosuppression and sulfa‐trimethoprime prophylaxis. Of the 30 patients on prophylactic anti‐CMV globulin, 21 (70%) became CMV‐positive and 11 patients (37%) developed virologically confirmed CMV disease. Two additional patients had fever without other signs of CMV disease. Two patients developed interstitial pneumonitis (IPn). Eleven (37%) patients developed acute rejection and had symptomatic CMV disease after transplantation. CMV disease developed earlier in patients treated for rejection with antithymocyte globulin (ATG) than in patients treated with methylprednisolone. In the historical control group, 5 patients (33%) developed CMV disease and 1 of them had pneumonitis. Seven patients (47%) underwent episodes of acute rejection and 3 of them had CMV disease at the same time. There were no opportunistic infections in cither group.