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

Chronic Allograft Nephropathy Clinical Trial

— RSCS-Campath  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01346397
• Other study ID #: RSCS-Campath-06
• Status: Recruiting
• Phase: N/A
• First received: July 7, 2010
• Last updated: December 6, 2012
• Start date: September 2010
• Est. completion date: September 2014

Study information

• Verified date: December 2012
• Source: Russian Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Observational [Patient Registry]

Clinical Trial Summary

After Campath 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 60 Years

Eligibility

Inclusion Criteria:

• recipient of kidney allograft

• previous Campath induction

Exclusion Criteria:

• CNI intolerance

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Graft Rejection
• Chronic Allograft Nephropathy
• Kidney Diseases
• Polyomavirus-related Transplant Nephropathy

Locations

Country	Name	City	State
Russian Federation	National Research Centre of Surgery	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Russian Academy of Medical Sciences	Russian Scientific Center of Surgery

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient survival		10 years	Yes
Primary	Graft survival		10 years	No