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

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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	2026-10-01
Source	DOI 10.1016/S0140-6736(00)02480-6 · PMID 10963197

Extracted findings

These fields were extracted from the paper with AI assistance and have not been checked against the source. Read them as a pointer into the paper, not as curated claims; where they disagree with the curated summary above, the curated summary stands.

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

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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}
}

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