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NCT Number: NCT02907554

Cyclosporine A Pretreatment and Kidney Graft Function

Organ donors included in the study are randomized to a control group or an intervention group receiving 2.5 mg/kg of cyclosporine A before organ procurement. Harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. According to the pretreatment of the transplant, delayed graft function during the first week was evaluated as well as kidney function at different timepoints and mortality during the first year after transplantation.

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Key information

About this study

Organ donors included in the study are randomized to a control group receiving a placebo or an intervention group receiving 2.5 mg/kg of cyclosporine A before organ procurement. In the operating theater organs are harvested. Thereafter, harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. The management of transplanted patients is performed as usual. According to the pretreatment of the transplant, delayed graft function during the first week (need of at least one dialysis session) was evaluated as well as kidney function at different timepoints (slow graft function, estimated creatinine clearance on day 3 and 7, acute and chronic graft rejection), length of hospital stay and mortality during the first year after transplantation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For organ donors:

  • Male and females aged 18 to 80 years
  • Brain death

Inclusion criteria

for organ recipients:

  • Male and females aged 18 to 80 years
  • Indication of kidney transplantation
  • Informed consent

Exclusion criteria

For organ donors:

  • Contra-indication for multiorgan procurement (infections, cancer, etc)
  • Preexistent chronic renal failure.
  • Refusal for organ procurement by the donor (confirmed by the French national register or reported by the next-of-kin).

Exclusion criteria

for organ recipients:

  • Need for a double kidney transplantation.
  • Need for a multiorgan transplantation

Treatment and study plan

Cyclosporine A

Drug

the intervention group receives 2.5 mg/kg of cyclosporine

Placebo

Drug

control group receives a placebo

Primary outcomes

  1. Percentage of delayed graft function defined by a need of at least one hemodialysis session

    Time frame: within the 7 days following renal transplantation.

Secondary outcomes

  1. Percentage of slow graft function defined by a urine output < 1000 ml

    Time frame: at on 1 day after transplantation

  2. Percentage of slow graft function defined by a decrease in plasma creatinine concentration of less than 30% or 70%

    Time frame: at day 3 and 7 after transplantation

  3. Postoperative evolution of estimated creatinine clearance

    Time frame: at day 3 and 7

  4. Percentage of acute and chronic graft rejection

    Time frame: during the first year after transplantation

  5. Percentage of primary graft dysfunction

    Time frame: during the first year after transplantation

  6. hospital length of stay

    Time frame: at day 1

    after transplantation

  7. Mortality

    Time frame: during the first year after transplantation

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Centre Hospitalier Universitaire de Nice
  • Centre Hospitalier Universitaire de Nīmes
  • Groupe Hospitalier Pitie-Salpetriere
  • Hôpital de la Timone
  • Hôtel Dieu (Nantes)
  • Poitiers University Hospital
  • University Hospital, Estaing
  • University Hospital, Montpellier
  • University Hospital, Toulouse

Registry information

Official study title

Effects of Cyclosporine A Pretreatment of Deceased Donor on Kidney Graft Function: A Randomized Controlled Trial

Acronym: Cis-A-Rein

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Sep 20, 2016
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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