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

NCT01560572 | Completed Phase 4 DMC

• 1 other identifier: Allegro
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Renal Insufficiency; Kidney Transplantation

Keywords

kidney transplantation; immunosuppression; steroids; tacrolimus OD

Outcome Measures

Primary Outcomes (1)

• renal function parameters

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

  24 months

Secondary Outcomes (7)

• tubular atrophy and interstitial fibrosis

  24 months

• rejection episodes

  two years

• graft and patient survival

  two years

• myocardial infarctions

  two years

• cerebrovascular accidents

  two years

Study Arms (3)

standard immunosuupression

ACTIVE COMPARATOR

triple maintenance immunosuppression with tacrolimus OD (maintenance 6-10 ng/ml), mycophenolic acid 2 dd 540mg and prednisolone 7.5 mg

Drug: tacrolimus OD, mycophenolic acid, prednisolone

steroidfree

EXPERIMENTAL

maintenance immunosuppression with tacrolimus OD (target range 6-10 ng/ml), mycophenolic acid (2 dd 540 mg)

Drug: tacrolimus OD, mycophenolic acid, prednisolone

low dose tacrolimus

EXPERIMENTAL

triple maintenance immunosuppression with tacrolimus OD (maintenance 6-10 ng/ml), mycophenolic acid 2 dd 540mg and prednisolone 7.5 mg. After 6 months lowering of tacrolimus OD maintenance 3-5 ng/ml

Drug: tacrolimus OD, mycophenolic acid, prednisolone

Interventions

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

Also known as: advagraf, mycophenolic acid

low dose tacrolimus; standard immunosuupression; steroidfree

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

Academisch Medisch Centrum

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Related Publications (1)

• van den Born JC, Meziyerh S, Vart P, Bakker SJL, Berger SP, Florquin S, de Fijter JW, Gomes-Neto AW, Idu MM, Pol RA, Roelen DL, van Sandwijk MS, de Vries DK, de Vries APJ, Bemelman FJ, Sanders JSF. Comparison of 2 Immunosuppression Minimization Strategies in Kidney Transplantation: The ALLEGRO Trial. Transplantation. 2024 Feb 1;108(2):556-566. doi: 10.1097/TP.0000000000004776. Epub 2024 Jan 19.

  PMID: 37650722 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Mycophenolic Acid; Prednisolone

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jan-Stephan Sanders, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: March 22, 2012
• Study Start: April 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2016
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

NL (3)