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Completed

NCT Number: NCT01560572

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

A prospective, open, randomized trial, in which the investigators aim to achieve optimal immunosuppression after renal renal transplantation with maximal reduction of side effects, especially of vascular injury, chronic allograft nephropathy, osteoporosis and malignancies. Immunosuppression without steroids and CNI minimization is compared to standard immunosuppression, consisting of tacrolimus OD, mycophenolic acid and corticosteroids.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Academisch Medisch Centrum, Amsterdam, Netherlands

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About this study

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 24 months after transplantation. Renal function will be measured by serum Creatinine, Creatinine clearances and CKD-EPI. 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 Criteria for Renal Allograft Biopsy Interpretation. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tacrolimus OD, mycophenolic acid, prednisolone

Drug

tacrolimus maintenance 6-10 ng/ml, in the low dose tacrolimus group after 6 months fixed dose reduction of 50% tacrolimus through levels will be 3-5 ng/ml mycophenolic acid 2 dd 720mg, after 2 weeks reduced to 2 dd 540 mg in all groups methylprednisolone 500, 250, 125 mg on day 0, 1, and 2 in all groups prednisolone 1 dd 10 mg, and from week 6 prednisolone 7.5 mg in the standard immunosuppression and low dose tacrolimus group No prednisolone will be given the steroid free group

Other names: advagraf, mycophenolic acid

Primary outcomes

  1. renal function parameters

    Time frame: 24 months

    renal function as measured by serum Creatinine and Creatinine Clearance, CKD-EPI, proteinuria

Secondary outcomes

  1. tubular atrophy and interstitial fibrosis

    Time frame: 24 months

    tubular atrophy and interstitial fibrosis in renal biopsies

  2. rejection episodes

    Time frame: two years

    number of treated biopsy proven acute rejection episodes (as scored by pathologist via Banff classification)

  3. graft and patient survival

    Time frame: two years

    graft and patient survival

  4. myocardial infarctions

    Time frame: two years

    number of myocardial infarctions

  5. cerebrovascular accidents

    Time frame: two years

    number of cerebrovascular accidents

  6. number of participants with infectious complications

    Time frame: two years

    bacterial and viral infections as measured by culture (bacterial infections) or PCR (viral infections)

  7. number of participants with osteoporosis

    Time frame: 2 years

    as established by dexa bone densitometry

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Leiden University Medical Center

Registry information

Acronym: Allegro

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Mar 22, 2012
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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