The Vienna Prograf and Endothelial Progenitor Cell Study

NCT00182559 | Completed Phase 4

• 2 other identifiers: 2004-004209-98393/2004
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to determine if the conversion from the immunosuppressive agent cyclosporine to tacrolimus contributes to an improvement of the cardiovascular risk factors, better kidney function and immune system.

Conditions

End Stage Renal Disease

Keywords

kidney; transplantation; tacrolimus; cyclosporine; conversion

Outcome Measures

Primary Outcomes (1)

• Change in endothelial progenitor cells from baseline to month 24

  The primary endpoint was the effect of conversion from ciclosporin to tacrolimus based immunosuppressive therapy on endothelial progenitor cell count at month 24.

  Baseline and 24 months

Secondary Outcomes (1)

• Renal function at baseline and after 24 months

  Baseline, 24 months

Study Arms (2)

Ciclosporin

ACTIVE COMPARATOR

Maintain ciclosporin in combination with/without mycophenolate mofetil and with/without steroids at target trough levels of 70-150ng/mL.

Drug: Ciclosporin

Tacrolimus

ACTIVE COMPARATOR

Conversion from ciclosporin to tacrolimus at target trough levels of 5-8 ng/mL in combination with/without mycophenolate mofetil and with/without steroids.

Drug: Tacrolimus

Interventions

Ciclosporin DRUG

Maintain ciclosporin in combination with/without mycophenolate mofetil and with/without steroids at target trough levels of 70-150ng/mL.

Also known as: Sandimmun Neoral

Ciclosporin

Tacrolimus DRUG

Conversion from ciclosporin to tacrolimus at target trough levels of 5-8 ng/mL in combination with/without mycophenolate mofetil and with/without steroids.

Also known as: Prograf

Tacrolimus

Eligibility Criteria

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

You may qualify if:

• Patient is recipient of a deceased or living donor renal transplant (including retransplants) Patient is 18 years or age or older at the time of transplantation. Patient is at least 6 months post-transplant. Patient is on a cyclosporine-based immunosuppression regimen o combination with/without mycophenolate mofetil and/or steroids at study entry.
• Patient has a functioning renal allograft and estimated GFR≥39 mL/min/1.73m2 within four weeks prior to study entry.
• Patient has a stable graft function without biopsy proven acute rejection episode within 3 months prior to study entry.
• Patient has not experienced a cardiovascular event. Patient has fully been informed and has given written informed consent according to the International Conference on Harmonization, Good Clinical Practice.
• Females are not pregnant and agree to practice effective birth control while receiving immunosuppressant medication.
• Patient has indications for conversion at the investigators discretion or is suffering from cyclosporine associated side effects like hypertension, hyperlipidemia or cosmetic side effects.

You may not qualify if:

• Patient is recipient of a solid organ transplant other than the kidney. Patient has recurrence of primary renal disease, or de novo renal disease. Patient is pregnant or lactating. Patient had known or suspected malignancy (except for treated squamous and basal cell skin cancers) \<5 years before study entry or a history of post-transplant lymphoproliferative disease (PTLD).
• Patient has known hypersensitivity to tacrolimus, or any of the recipients of the drug.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (2)

• Plischke M, Riegersperger M, Dunkler D, Heinze G, Kikic Z, Winkelmayer WC, Sunder-Plassmann G. Late Conversion of Kidney Transplant Recipients from Ciclosporin to Tacrolimus Improves Graft Function: Results from a Randomized Controlled Trial. PLoS One. 2015 Aug 13;10(8):e0135674. doi: 10.1371/journal.pone.0135674. eCollection 2015.

  PMID: 26270340 DERIVED

• Riegersperger M, Plischke M, Steiner S, Seidinger D, Sengoelge G, Winkelmayer WC, Sunder-Plassmann G. Effect of conversion from ciclosporin to tacrolimus on endothelial progenitor cells in stable long-term kidney transplant recipients. Transplantation. 2013 Jun 15;95(11):1338-45. doi: 10.1097/TP.0b013e31828fabb3.

  PMID: 23594858 DERIVED

Related Links

• Website of the Medical University Vienna

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Cyclosporine; Tacrolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Macrolides; Lactones; Organic Chemicals

Study Officials

• Gere Sunder-Plassmann, M.D.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Prof. Dr.

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 16, 2005
• Study Start: April 1, 2004
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: February 5, 2014

Record last verified: 2014-02

Locations

AU (1)