Format

Send to

Choose Destination
Transpl Int. 2016 Jan;29(1):41-50. doi: 10.1111/tri.12656.

Eight-year results of the Spiesser study, a randomized trial comparing de novo sirolimus and cyclosporine in renal transplantation.

Author information

1
Service de Néphrologie et Immunologie clinique, CHRU de Tours, Tours, France.
2
Université François-Rabelais de Tours, Tours, France.
3
Service de Néphrologie, CHU de Rouen, Rouen, France.
4
Service de Transplantation rénale, CHU de Reims, Reims, France.
5
Service de Néphrologie et Transplantation rénale, CHU de Caen, Caen, France.
6
Service de Néphrologie et Dialyse, CHU d'Amiens, Amiens, France.
7
Service de Néphrologie et Transplantation rénale, CHU de Limoges, Limoges, France.
8
Service de Néphrologie, CHU de Poitiers, Poitiers, France.
9
Service de Néphrologie-Dialyse-Transplantation, CHU d'Angers, Angers, France.
10
Service de Néphrologie et Transplantation rénale, CHRU de Strasbourg, Strasbourg, France.
11
Service de Transplantation rénale, AP-HP, Hôpital de Necker Enfants-Malades, Paris, France.
12
Service de Néphrologie, CHU de Rennes, Rennes, France.
13
Service de Néphrologie et Transplantation rénale, CHU de Clermont-Ferrand, Clermont-Ferrand, France.

Abstract

We present the results at 8 years of the Spiesser study, a randomized trial comparing de novo sirolimus and cyclosporine in kidney transplant recipients at low immunologic risk. We assessed estimated glomerular filtration (eGFR), graft, patient, and death-censored graft survival (log-rank compared), de novo DSA appearance, risk of malignancy, post-transplant diabetes mellitus (PTDM), and anemia. Intent-to-treat and on-treatment analyses were performed. Graft survival was similar in both groups (sirolimus: 73.3%, cyclosporine: 77.7, P = 0.574). No difference was observed between treatment groups concerning patient survival (P = 0.508) and death-censored graft survival (P = 0.858). In conditional intent-to-treat analysis, mean eGFR was greater in sirolimus than in cyclosporine group (62.5 ± 27.3 ml/min vs. 47.8 ± 17.1 ml/min, P = 0.004), in particular because graft function was excellent in patients maintained under sirolimus (eGFR = 74.0 ml/min). Importantly, no detrimental impact was observed in patients in whom sirolimus has been withdrawn (eGFR = 49.5 ml/min). Overall, 17 patients showed de novo DSAs, with no difference between the two groups (P = 0.520). Malignancy did not differ by treatment. An initial maintenance regimen based on sirolimus provides a long-term improvement in renal function for kidney transplant patients, especially for those maintained on sirolimus.

KEYWORDS:

clinical trial; human leukocyte antigen-antibody posttransplantation; immunosuppression; kidney transplantation; target of rapamycin-inhibitors

PMID:
26285161
DOI:
10.1111/tri.12656
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Wiley
Loading ...
Support Center