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Brain DeathPhase 4Cis-A-ReinNCT02907554

Cyclosporine A Pretreatment and Kidney Graft Function

A Phase 4 study testing cyclosporine A in people with Brain Death and Kidney Transplantation, run by University Hospital, Clermont-Ferrand at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Brain Death, Kidney Transplantation
What is being tested?
cyclosporine A
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
648 participants
Where
1 siteFrance
Study dates
19 Dec 2017to 3 Apr 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For organ donors:
  • Male and females aged 18 to 80 years
  • Brain death
  • Male and females aged 18 to 80 years
  • Indication of kidney transplantation
  • Informed consent

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
cyclosporine A, Placebo
Keywords
Preconditioning, Tissue and organ procurement, Cyclosporine A, Kidney transplantation, Delayed graft function
Medical subject headings
Brain Death, Delayed Graft Function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cyclosporine ADrug

    the intervention group receives 2.5 mg/kg of cyclosporine

  • PlaceboDrug

    control group receives a placebo

Study groups in NCT02907554
Study groupRoleWhat they receive
control groupPlacebo comparatorcontrol group receives a placebo
Receives: Drug: Placebo
intervention groupExperimentalthe intervention group receives 2.5 mg/kg of cyclosporine
Receives: Drug: cyclosporine A

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: within the 7 days following renal transplantation.

Secondary outcomes (7)

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

    Measured: 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%

    Measured: at day 3 and 7 after transplantation

  3. Postoperative evolution of estimated creatinine clearance

    Measured: at day 3 and 7

  4. Percentage of acute and chronic graft rejection

    Measured: during the first year after transplantation

  5. Percentage of primary graft dysfunction

    Measured: during the first year after transplantation

  6. hospital length of stay

    after transplantation

    Measured: at day 1

  7. Mortality

    Measured: during the first year after transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2016 (estimated)
  2. Study start19 Dec 2017
  3. Primary completion10 Apr 2022
  4. Study completion3 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
648 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02907554
Sponsor's protocol ID
RBHP_2014_CONSTANTIN
Other IDs
2014-003544-12, 2014
Acronym
Cis-A-Rein
Status last verified
Jul 2026
First submitted
5 Sep 2016
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ichai C, Fontaine E, Baumstarck K, Rimmele T, Strecker G, Boucekine M, Szabo V, Gosset C, Heng AE, Kerforne T, Naboulsi E, Velly L, Leone M, Pottecher J, Depret F, Margetis D, Bouhemad B, Orban JC, Leroy A, Riou B, Borao L, Constantin JM; Cis-A-Rein Group. Cyclosporine versus placebo pretreatment of brain-dead donors and kidney graft function (Cis-A-Rein trial): a multicenter, double-blind, randomized, controlled trial. Intensive Care Med. 2026 Feb;52(2):289-300. doi: 10.1007/s00134-025-08265-6. Epub 2026 Jan 8.

    PubMed 41504889

  • Orban JC, Fontaine E, Cassuto E, Baumstarck K, Leone M, Constantin JM, Ichai C; AzuRea network. Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial. Trials. 2018 Apr 17;19(1):231. doi: 10.1186/s13063-018-2597-4.

    PubMed 29665840

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing cyclosporine A in people with Brain Death and Kidney Transplantation, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of delayed graft function defined by a need of at least one hemodialysis session (time frame: within the 7 days following renal transplantation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02907554, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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