The Vienna Prograf and Endothelial Progenitor Cell Extension Study
PEP-X
2 other identifiers
interventional
87
0 countries
N/A
Brief Summary
Conversion of renal transplant recipients from either tacrolimus or cyclosporin A to tacrolimus modified release to investigate the effects of the MDR1/CYP450 genotype on the trough blood levels of tacrolimus with modified galenic (tacrolimus MR4; Advagraf®).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2008
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 9, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedNovember 23, 2018
November 1, 2018
2.6 years
November 9, 2018
November 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effects of the MDR1 genotype on the trough blood levels of tacrolimus with modified galenics (tacrolimus MR4; Advagraf®)
Effects of the genotype on the concentration/dose ratio (\[ng/mL\]/\[mg/d\])
12 months
Study Arms (1)
Conversion from either CSA or TAC
OTHERTacrolimus with modified galenic (tacrolimus MR4; Advagraf®) once daily. In patients treated with ciclosporin A, the initial dose will be 0.1 - 0.12 mg tacrolimus MR4 per kg of body weight per day with oral morning administration. In patients who are already treated with Prograf, the conversion to Advagraf will be performed in a 1:1 ratio.
Interventions
Conversion from either cyclosporin or tacrolimus to tacrolimus modified release
Eligibility Criteria
You may qualify if:
- Any stable long-term kidney transplant recipient who participated in the Vienna Prograf and Endothelial-Progenitor Study (Vienna PEP Study; EudraCT identifier 2004-82 004209-98)
- Written informed consent to have the immunosuppression converted from either cyclosporin A or tacrolimus to tacrolimus modified-release
You may not qualify if:
- Graft failure
- Contraindication to receive immunosuppression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Riegersperger M, Plischke M, Jallitsch-Halper A, Steinhauser C, Fodinger M, Winkelmayer WC, Dunkler D, Sunder-Plassmann G. A non-randomized trial of conversion from ciclosporin and tacrolimus to tacrolimus MR4 in stable long-term kidney transplant recipients: Graft function and influences of ABCB1 genotypes. PLoS One. 2019 Jul 2;14(7):e0218709. doi: 10.1371/journal.pone.0218709. eCollection 2019.
PMID: 31266056DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gere Sunder-Plassmann, MD
Medical University of Vienna
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor of Medicine
Study Record Dates
First Submitted
November 9, 2018
First Posted
November 23, 2018
Study Start
March 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
November 23, 2018
Record last verified: 2018-11