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

NCT01346397 | Completed Results

• 1 other identifier: RSCS-Campath-06
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Graft Rejection; Chronic Allograft Nephropathy; Polyomavirus-related Transplant Nephropathy

Keywords

rejection; survival; alemtuzumab; cyclosporine; tacrolimus

Outcome Measures

Primary Outcomes (2)

• Patient Survival

  in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%

  5 years

• Graft Survival

  in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%

  5 years

Study Arms (2)

cyclosporine group

cyclosporine group - after alemtuzumab induction cyclosporine was administered

Drug: cyclosporine or tacrolimus

tacrolimus group

tacrolimus group - after alemtuzumab induction tacrolimus was administered

Drug: cyclosporine or tacrolimus

Interventions

cyclosporine or tacrolimus DRUG

after alemtuzumab, cyclosporine or tacrolimus was administered

cyclosporine group; tacrolimus group

Eligibility Criteria

• Age: 6 Months - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• first kidney allograft recipients
• alemtuzumab induction

You may not qualify if:

• CNI intolerance

Sponsors & Collaborators

• Russian Academy of Medical Sciences: lead
• Russian Scientific Center of Surgery: collaborator

Study Sites (1)

National Research Centre of Surgery

Moscow, 119992, Russia

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood and urine, taken at the time of protocol or case biopsies will be deeply freeze and stocked for future examination for NAT or other molecules - candidates for diagnostic markers.

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Cyclosporine; Tacrolimus

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Dr Michael Kaabak
• Organization: Boris Petrovsky research cener od surgery

kaabak@hotmail.com

+74992481344

Study Officials

• Michael M Kaabak, professor

  Russian Scientific Center of Surgery RAMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: May 3, 2011
• Study Start: April 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2016
• Last Updated: November 29, 2016
• Results First Posted: November 29, 2016

Record last verified: 2016-10

Locations

RU (1)