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Delayed Graft Function and immunosuppressive Regimen effects IF/TA Progression in the First Year after Renal Transplantation.


- candidate number8312
- NTR NumberNTR2456
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-aug-2010
- Secondary IDs10-4-008 METC MUMC
- Public TitleDelayed Graft Function and immunosuppressive Regimen effects IF/TA Progression in the First Year after Renal Transplantation.
- Scientific TitleDelayed Graft Function and immunosuppressive Regimen effects IF/TA Progression in the First Year after Renal Transplantation.
- ACRONYM
- hypothesisIn this study we will investigate the progression of IF/TA in protocol biopsies in a cohort of renal transplants, with a steroid sparing TAC-based immunosuppressive regimen in combination with either sirolimus (SRL) or mycophenolate mofetil (MMF), during the first year after renal transplantation. Furthermore we will investigate if the progression of IF/TA is correlated with donor -, recipient -, and transplant factors, to give insight in potential modifiable and non-modifiable factors associated with this progression.
- Healt Condition(s) or Problem(s) studiedRenal transplant , Protocol biopsy, Immunosuppression, Interstitial fibrosis, Tubular atrofy
- Inclusion criteria1. Patients transplanted between 2003 and February 2008;
2. An adequate T0 and T12 biopsy;
3. Tacrolimus-based regimen with either SRL or MMF;
4. Age between 18 and 80 years.
- Exclusion criteria1. Other immunosuppressive regimen than tacrolimus, either SRL or MMF;
2. Patients with missing biopsies.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 17-mrt-2010
- planned closingdate1-dec-2010
- Target number of participants110
- InterventionsN/A
- Primary outcomeProgression in IF/TA (Chamge in IF/TA between implantation and at month 12.
- Secondary outcomeFactors associated with this progression.
- Timepoints1. At implantation of donor kidney;
2. At month 12 after transplantation.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Marielle Gelens
- CONTACT for SCIENTIFIC QUERIES Marielle Gelens
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- PublicationsN/A
- Brief summaryIn this study we will investigate the progression of IF/TA in protocol biopsies in a cohort of renal transplants, with a steroid sparing TAC-based immunosuppressive regimen in combination with either sirolimus (SRL) or mycophenolate mofetil (MMF), during the first year after renal transplantation. Furthermore we will investigate if the progression of IF/TA is correlated with donor -, recipient -, and transplant factors, to give insight in potential modifiable and non-modifiable factors associated with this progression.
- Main changes (audit trail)
- RECORD5-aug-2010 - 23-aug-2010


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