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Steroid Free Immunosuppression or Calcineurin Inhibitor Minimization After Basiliximab Induction Therapy in Kidney Transplantation: Comparison With a Standard Quadruple Immunosuppressive Regimen


Phase 4
18 Years
80 Years
Open (Enrolling)
Both
Renal Insufficiency, Kidney Transplantation

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Trial Information

Steroid Free Immunosuppression or Calcineurin Inhibitor Minimization After Basiliximab Induction Therapy in Kidney Transplantation: Comparison With a Standard Quadruple Immunosuppressive Regimen


Before transplantation 300 patients will be randomized 1:1:1 in three groups. Group 1 will
be treated with basiliximab induction and a three day course of steroids followed by a
steroid free maintenance regimen consisting of standard-dose tacrolimus OD and mycophenolic
acid. Group 2 will be treated with Basiliximab induction followed by standard-dose
tacrolimus OD, mycophenolic acid and steroids. Group 3 will be treated with basiliximab
induction followed by standard-dose tacrolimus OD for six months, whereafter the dose will
be reduced plus mycophenolic acid and steroids. The total study period will be 2 years.
Primary endpoint will be renal function, proteinuria and microalbuminuria measured 6, 12,
and 24 months after transplantation. Renal function will be measured by serum Creatinine,
Creatinine clearances and Nankivell GFR (4). Secondary endpoints will be the degree of
tubular atrophy and interstitial fibrosis and the degree of arteriolar hyalinosis in renal
biopsies taken at 12 and 24 months after transplantation. Biopsies will be evaluated
according to the Banff '07 Criteria for Renal Allograft Biopsy Interpretation (appendix II).
Quantitative morphometric analysis of interstitial fibrous tissue will be performed using
the digital image analysis technique. Other secondary endpoints are patient and graft
survival, the incidence of allograft rejection, cardiovascular accidents, pulse wave
velocity, blood pressure, the number of antihypertensives, lipid profile, the incidence of
malignancies, the incidence of infectious complications, the incidence of post transplant
diabetes mellitus and the development of osteoporosis.


Inclusion Criteria:



- recipient of a kidney graft (first of second) from a deceased or living (non-HLA
identical) donor

Exclusion Criteria:

- patients with multi-organ transplants

- patients who are receiving a third or fourth transplant

- patients who have > 75% (current of historic) panel reactive antibodies

- patients receiving a kidney from a HLA identical living donr

- female patients who are pregnant or unwilling to used adequate contraception during
the study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

renal function parameters

Outcome Description:

renal function as measured by serum Creatinine and Creatinine Clearance, Nankivell GFR, proteinuria and microalbuminuria

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Jan-Stephan Sanders, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Groningen

Authority:

Netherlands: Independent Ethics Committee

Study ID:

Allegro

NCT ID:

NCT01560572

Start Date:

April 2011

Completion Date:

April 2016

Related Keywords:

  • Renal Insufficiency
  • Kidney Transplantation
  • kidney transplantation
  • immunosuppression
  • steroids
  • tacrolimus OD
  • Renal Insufficiency

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