Efficacy of sirolimus compared with azathioprine for reduction of acute renal allograft rejection: a randomised multicentre study

Kahan BD (Rapamune US Study Group) · 2000 · Lancet · Atlas ID KAH2000

What this study shows

The trial that established rapamycin (sirolimus) as an immunosuppressant in kidney transplant patients - its original, still-standard clinical use.

Abstract

ShowHide

Acute rejection episodes after renal transplantation are an important clinical challenge, despite use of multidrug immunosuppressive regimens. We did a prospective, multicentre, randomised, double-blind trial to investigate the impact of the addition of sirolimus, compared with azathioprine, to a cyclosporin and prednisone regimen. 719 recipients of primary HLA-mismatched cadaveric or living-donor renal allografts who displayed initial graft function were randomly assigned, after transplantation, sirolimus 2 mg daily (n=284) or 5 mg daily (n=274), or azathioprine (n=161).

Read the full abstract on PubMed →

At a glance

Evidence type	H Human study Marked H because it is direct evidence from a human clinical trial or human cohort; the code names the kind of study, not its quality -- a small, well-run trial is still H.
Study type	2 - Human Clinical Trial
Model system	Humans, phase III RCT (n=719)
Journal	Lancet
Year	2000
Peer reviewed	Yes
Record last updated	2026-08-22
Source	DOI 10.1016/S0140-6736(00)02480-6 · PMID 10963197

Extracted findings

Intervention	Sirolimus (vs azathioprine; + cyclosporine/prednisone)
Target	mTOR
Model	Human – phase III RCT (n=719, renal transplant)
Effect	Adding sirolimus reduced acute renal allograft rejection compared with azathioprine

In the Atlas

Cite this paper

ShowHide

Kahan BD (Rapamune US Study Group) (2000). Efficacy of sirolimus compared with azathioprine for reduction of acute renal allograft rejection: a randomised multicentre study. Lancet. https://doi.org/10.1016/S0140-6736(00)02480-6

@article{KAH2000,
  author       = {Kahan BD (Rapamune US Study Group)},
  title        = {{Efficacy of sirolimus compared with azathioprine for reduction of acute renal allograft rejection: a randomised multicentre study}},
  journal      = {Lancet},
  year         = {2000},
  doi          = {10.1016/S0140-6736(00)02480-6},
  note         = {PMID: 10963197},
}

Cite this Atlas record

The record is the Atlas's own work — the evidence label, the extracted findings and the links. It is cited as part of the dataset, not as the paper.

Barton, O. (2026). Oliver's mTOR Atlas (record KAH2000) [Data set]. https://mtor-atlas.org/study/KAH2000/ · Dataset DOI 10.5281/zenodo.22059963

@misc{atlas_KAH2000,
  author       = {Barton, Oliver},
  title        = {{Oliver's mTOR Atlas}, record KAH2000},
  howpublished = {Data set},
  year         = {2026},
  url          = {https://mtor-atlas.org/study/KAH2000/},
  doi          = {10.5281/zenodo.22059963}
}