Acute Graft RejectionRSCS-CampathNCT01346397

Study Cyclosporine (CsA) Versus Tacrolimus (Tacro) After Campath Induction in Kidney Transplantation

An observational study of Acute Graft Rejection and Chronic Allograft Nephropathy, run by Russian Academy of Medical Sciences at 1 site in Russia.

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

Who is it for?: Ages 6 months to 60 years
Conditions the study is for: Acute Graft Rejection, Chronic Allograft Nephropathy, Polyomavirus-related Transplant Nephropathy
What is being tested?: cyclosporine or tacrolimus
How many people: 170 participants
Where: 1 siteRussia
Study dates: Apr 2009to May 2016
How long will I take part?: 10 Years
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 6 months to 60 years
All sexes
No healthy volunteers
Child, Adult

Study population: Recipients of kidney allograft who underwent previous Campath induction and do receive calcineurine inhibitor (CNI)

Who may be able to join

first kidney allograft recipients
alemtuzumab induction

Who cannot join

CNI intolerance

Trial locations and contacts

1 site in 1 country.

Russia1 site

National Research Centre of Surgery
Moscow, 119992

Other trials in Russia

About this study

Official title: Prospective Randomized Trial Comparing CsA Versus Tacro After Campath Induction In Kidney Transplant Recipients

After alemtuzumab induction, followed with kidney transplantation, patients will be randomly assigned to receive either tacrolimus or cyclosporine microemulsion in combination with mycophenolates. Patients will be followed including protocol biopsy at 1, 12, 36, 60 month posttransplant, regular nuclein acid testing (NAT) for cytomegalovirus (CMV), Epstein-Barr virus (EBV) and BK virus (BKV) in urine and blood.

The investigation is undertaken to clarify the reason for equal survival rates for patients on cyclosporine and tacrolimus despite the lower rejection rate on tacrolimus.

Read the detailed description

Special attention will be paid to the epidemiology of virus infections behind one year post transplant. Very limited data are available on this issue and there is suspicion that tacrolimus patients suffer more hard with viruses like CMV, EBV, BKV. These viruses can induce graft nephropathy and threat to the life of the recipient.

Conditions: Acute Graft Rejection, Chronic Allograft Nephropathy, Polyomavirus-related Transplant Nephropathy
Being tested: cyclosporine or tacrolimus
Keywords: rejection, survival, alemtuzumab, cyclosporine, tacrolimus
Medical subject headings: Rejection, Psychology

What participants receive

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

cyclosporine or tacrolimusDrug
after alemtuzumab, cyclosporine or tacrolimus was administered

Study groups in NCT01346397
Study group	Role	What they receive
cyclosporine group		cyclosporine group - after alemtuzumab induction cyclosporine was administered Receives: Drug: cyclosporine or tacrolimus
tacrolimus group		tacrolimus group - after alemtuzumab induction tacrolimus was administered Receives: Drug: cyclosporine or tacrolimus

What is being measured

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

Patient Survival
in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%
Measured: 5 years
Graft Survival
in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%
Measured: 5 years

Timeline

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

Apr 2009May 2016

First posted3 May 2011 (estimated)
Study startApr 2009
Primary completionMay 2013
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Graft RejectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 170 participants (actual)
Target duration: 10 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT01346397
Sponsor's protocol ID: RSCS-Campath-06
Acronym: RSCS-Campath
Status last verified: Oct 2016
First submitted: 7 Jul 2010
Last updated: 29 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study of LBP-MARCO and Ruxolitinib in People With Graft-Versus-Host Disease (GVHD)
Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)
RecruitingEarly Phase 1
Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Bone Marrow or Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
Hematologic Malignancy, Bone Marrow Transplant Rejection
Active, not recruitingObservational study
Extended Validation of Donor-derived Cell-free DNA in Kidney Transplant Recipients
Rejection Acute Renal, Rejection Chronic Renal
RecruitingPhase 3
A Multicenter Randomized Controlled Trial to Treat Acute T Cell Mediated Rejection in Kidney and Kidney-Pancreas Transplant Recipients
Rejection; Transplant, Kidney, Rejection; Transplant, Pancreas
RecruitingObservational study
Dd-cfDNA and Treg in Prediction of Kidney Transplant Acute Rejection
Acute Rejection of Renal Transplant, Graft Failure

All Acute Graft Rejection trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Trial Comparing CsA Versus Tacro After Campath Induction In Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT01346397
Acronym / sponsor ID: RSCS-Campath / RSCS-Campath-06
Conditions: Acute Graft Rejection, Chronic Allograft Nephropathy, Polyomavirus-related Transplant Nephropathy
Keywords: rejection, survival, alemtuzumab, cyclosporine, tacrolimus
Study type: Observational
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: Russian Academy of Medical SciencesUniversity, hospital or other
Collaborators: Russian Scientific Center of Surgery
Study start: Apr 2009
Primary completion: May 2013 (actual)
Study completion: May 2016 (actual)
First posted: 3 May 2011 (estimated)
Results: Posted 29 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigation is undertaken to clarify the reason for equal survival rates for patients on cyclosporine and tacrolimus despite the lower rejection rate on tacrolimus.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Target follow-up: 10 Years
Number of arms: 2

Arm	Type	Receives
cyclosporine group	–	Drug: cyclosporine or tacrolimuscyclosporine group - after alemtuzumab induction cyclosporine was administered
tacrolimus group	–	Drug: cyclosporine or tacrolimustacrolimus group - after alemtuzumab induction tacrolimus was administered

Who may qualify

Ages: 6 months to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Recipients of kidney allograft who underwent previous Campath induction and do receive calcineurine inhibitor (CNI)

Key inclusion criteria (2 listed)

first kidney allograft recipients
alemtuzumab induction

Key exclusion criteria (1 listed)

CNI intolerance

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cyclosporine or tacrolimusafter alemtuzumab, cyclosporine or tacrolimus was administered	Drug	cyclosporine group, tacrolimus group

Primary outcome

Patient Survival
Time frame: 5 years
in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%
Graft Survival
Time frame: 5 years
in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%

Results and safety

Results posted to the registry on 29 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cyclosporine Group	85	85
Tacrolimus Group	85	85

Primary outcome: Patient Survival

Time frame: 5 years. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cyclosporine Group n = 85	Tacrolimus Group n = 85
Value	96.4 (94 to 98.8)	96.3 (92.9 to 99.7)

Primary outcome: Graft Survival

Time frame: 5 years. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cyclosporine Group n = 85	Tacrolimus Group n = 85
Value	84.6 (78.7 to 90.5)	86.2 (82.6 to 93.5)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cyclosporine Group	13 of 85 (15.3%)	40 of 85 (47.1%)	Not reported
Tacrolimus Group	12 of 85 (14.1%)	12 of 85 (14.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acute Graft Rejection

RecruitingPhase 1
A Study of LBP-MARCO and Ruxolitinib in People With Graft-Versus-Host Disease (GVHD)
Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)
RecruitingEarly Phase 1
Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Bone Marrow or Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
Hematologic Malignancy, Bone Marrow Transplant Rejection
Active, not recruitingObservational study
Extended Validation of Donor-derived Cell-free DNA in Kidney Transplant Recipients
Rejection Acute Renal, Rejection Chronic Renal
RecruitingPhase 3
A Multicenter Randomized Controlled Trial to Treat Acute T Cell Mediated Rejection in Kidney and Kidney-Pancreas Transplant Recipients
Rejection; Transplant, Kidney, Rejection; Transplant, Pancreas
RecruitingObservational study
Dd-cfDNA and Treg in Prediction of Kidney Transplant Acute Rejection
Acute Rejection of Renal Transplant, Graft Failure

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael M Kaabak, professor principal investigator

Russian Scientific Center of Surgery RAMS

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Graft Rejection and Chronic Allograft Nephropathy, run by Russian Academy of Medical Sciences at 1 site in Russia.

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 2 inclusion and 1 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 29 Nov 2016. 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 Russia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patient Survival (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT01346397.

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 29 Nov 2016.