NCT01195194

Selection of Immunosuppression in Kidney Transplant Recipients Depending on Pre-transplant Donor-specific T-cell Reactivity.

Pilot Study of Selection of Either Calcineurin Inhibitor(CNI)-Based or CNI-free Immunosuppressive Regimen Depending on the Result of Pre-transplantation Donor-specific T-cell Reactivity Measured by Enzyme-linked Immunosorbent Spot(ELISPOT) in Standard-risk Kidney Recipients.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Josep M Grinyo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective is to assess if low pre-transplantation donor specific T-cell reactive patients measured by Enzyme-linked immunosorbent spot (ELISPOT)assay can be safely managed with Calcineurin inhibitor(CNI)-free Sirolimus(SRL)-based immunosuppression.

Detailed description

Non randomized, pilot, prospective, open-label trial.

Conditions

• Disorder Related to Renal Transplantation

Interventions

Type	Name	Description
DRUG	PRE-TRANSPLANT (PRE=before)	All patients will start with Thymoglobulin 1 mg/kg before transplant followed by 0,5 mg/kg/d during the next 5 days (total accumulated 3,5 mg/kg). Steroids will be administered at 0,25 mg/kg/d until month 3rd, followed by 0,1 mg/kg/d thereafter. Mycophenolate Mofetil: Pre-transplant 2 grams iv. After transplantation 1g/12 hours, starting iv and changing to oral formulation as soon as patient starts with oral intake (targeting mycophenolic acid (MPA) C0h levels 2-5 µg/mL).

Timeline

• Start date: 2008-03-01
• Primary completion: 2012-06-01
• Completion: 2013-06-01
• First posted: 2010-09-06
• Last updated: 2014-02-25

Locations

2 sites across 1 country: Spain