Hakala, T

Iwatsuki, S

Klintmalm, GBG

Starzl, TE

D-Scholarship@Pitt

Cyclosporin A and Kidney Transplantation: Present Status of a Partially Randomized Trial G. B. G. Klintmalm. T. E. Starzl. S. Iwatsuki. and T. Hakala REPORTS concerning the use of Cyclos-porin A (CY-A) in kidney transplanta-tion in non randomized trials with consider-able numbers of patients and long follow-up have been presented by several centers, some with exciting results,I.' some with less exciting results.JA Randomized trials have been under way for a more limited time, and it is not until recently that the first report was made.s This is an update of the trial conducted at the University of Pittsburgh. MATERIALS AND METHODS Between March and August 1981.40 patients received primary kidney transplants. By randomization. and six compassionate releases. 21 patients were treated with CY -A and prednisone (Pred), and 19 with azathioprine (Aza) and Pred. Parallel to the partially randomized trial in primary cadaver kidney transplantation. a nonrandom-ized trial was conducted using the following described CY-A-Pred protocol alone in patients being retrans-planted. Twenty-two patients received their second or third graft. Prior to the transplant. all primary graft recipients were given at least three blood transfusions. In all recip-ients. some attempts were made to match donors and recipients, resulting in a HLA-A.B match of 1.3 :!: 1.3 (SO). The DR matching was random. The recipients were 8-{)4 years of age. with a mean of 33 years. The CY-A and Pred treatment principles were as follows: CY-A was given 17.5 mg/kg/day orally as one dose prior to the transplant. This dose was then main-tained postoperatively. half of the dose being given every 12 hr. Reductions of this dose were made at the occur-rence of toxicity. One gram of methylprednisolone was given i.v. during the transplantation. Postoperatively. prednisolone was administered 200 mg/day with daily From the Department of Surgery. University of Pills-burgh Health Sciences Center. Pittsburgh. Pa. Supported by the Veterans Administrations Grants AM-I7260 and AM-07772 and National Institutes of Health Grants RR-00051 and RR-00069. Reprint requests should be addressed to G. Klint-maim, M.D .. Department of Surgery, Karolinska Insti-tute. Huddinge Hospital. S-141 86 Huddinge. Sweden, 10 1982 by Grune & Stralton. Inc. 0041-1345/82/1401--0027$01.00/0 98 reductions of 40 mg/day until day 6. when 20 mg/day' was given. This was the maintenance dose for 2 months, , whereafter the prednisolone was reduced to 10 mg/day if. kidney function was satisfactory, In face of rejection. the intravenoius and oral steroid schedule described was' repeated. The treatment is described in detail elsewhere.' The Aza- and Pred- treated patients were treated in the customary way for kidney transplantation at the Univer-sity of Pittsburgh :-.1edical School. RESULTS PartialJy Randomi:ed Patients In 21, the primary cadaveric graft r"r·,"'::'._ ients receiving treatment with CY-A Pred. only one kidney has been lost. This due to an accidental donation of a blood A kidney to a blood group 0 recipient. ing in a renal vein thrombosis. In 19. the primary cadaveric treated with Aza and Pred, six (32%) have been lost to date. Nonrandomi:ed Patients ' Of the 21 patients that have been planted, three (14%) have lost their g Two of the grafts were lost by rejection. one by a technical error resulting artery thrombosis. Mortality and Morbidity There have been no deaths in any of patient groups. A pneumocystis carinii ' tion has occurred in one of the primary recipients treated with CY -A and Pred. infection has been successfully treated antibiotics. Tabl.1. Follow-Up at 0.5-6.5 Months Randomized (Primary Cadaveric Transp'antsl CY-A Azathioprine Transplants 21 19 Lost grafts 1 6 4 Mortality 0 0 0 Transplantation Proceedings. Vol. XIV. No.1 (MarchI. · CYCLOSPORIN A AND RENAL TRANSPLANTATION DISCUSSION The interpretation of these results must be cautiously because of the short follow-up (2 weeks to 6'/2 months). Still. it excites high hopes in CY -A as a major immunosup-ive agent for the future. REFERENCES I. Starzl TE. Klintmalm GBG. Wei I R III. el al: Surg Obslct 153:486. 1981 99 2. Caine RY. White DJG. Evans DG. et al: Br Mcd J 282:934. 198 I 3. Sweny P. Farrington K. Younis F. el al: Transplant Proc 13:365. 1981 4. Carpenter BJ. Tilney NL. Strom TB. et al: Kidney Int 19:265. 1981 5. Rynasiewicz JJ. Sutherland DE. Najarian JS: Pre-sentation at the American Society of Transplant Sur-geons Seventh Annual Scientific Meeting. Chicago. June 4-5. 1981. 

Cyclosporin A and kidney transplantation: Present status of a partially randomized trial

Hakala, TR

Name not available

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Cyclosporin A and kidney transplantation: Present status of a partially randomized trial

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