Cyclosporine A Pretreatment and Kidney Graft Function (Cis-A-Rein)

July 31, 2026 updated by: University Hospital, Clermont-Ferrand

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

648

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU clermont-ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
control group receives a placebo
Drug: Placebo
control group receives a placebo
Experimental: intervention group
the intervention group receives 2.5 mg/kg of cyclosporine
Drug: cyclosporine A
the intervention group receives 2.5 mg/kg of cyclosporine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of delayed graft function defined by a need of at least one hemodialysis session
Time Frame: within the 7 days following renal transplantation.
within the 7 days following renal transplantation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of slow graft function defined by a urine output < 1000 ml
Time Frame: at on 1 day after transplantation
at on 1 day after transplantation
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
at day 3 and 7 after transplantation
Postoperative evolution of estimated creatinine clearance
Time Frame: at day 3 and 7
at day 3 and 7
Percentage of acute and chronic graft rejection
Time Frame: during the first year after transplantation
during the first year after transplantation
Percentage of primary graft dysfunction
Time Frame: during the first year after transplantation
during the first year after transplantation
hospital length of stay
Time Frame: at day 1
after transplantation
at day 1
Mortality
Time Frame: during the first year after transplantation
during the first year after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

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

Investigators

  • Principal Investigator: Carole ICHAI, Centre Hospitalier Universitaire De Nice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2017

Primary Completion (Actual)

April 10, 2022

Study Completion (Actual)

April 3, 2023

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (Estimated)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP_2014_CONSTANTIN
  • 2014-003544-12 (Other Identifier: 2014-003544-12)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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