Clinical Trials Logo
  1. Home
  2. Renal Transplantation
  3. NCT00978965

Identification of Patients With High Probability of Poorly Responding to Therapy With Mycophenolic Acid Prodrugs

Renal Transplantation Clinical Trial

Official title:
Identification of Patients With High Probability of Not or Poorly Responding to Mycophenolate-mofetil (Cellcept®) or Mycophenolate-natrium (Myfortic®) Therapy

Clinical Trial Summary

This study is designed to define groups of patients (among patients with a heart or kidney graft or a glomerular disease and nephrotic range proteinuria) who would either not profit from a therapy with mycophenolate-mofetil (MMF) or need a higher than conventional dose to respond.

Mainly there are 2 possible explanations for inter-patient differences in responsiveness to MMF therapy:

1. Based on a mutation (in this study single nucleotide polymorphisms-SNPs-) in the inosine monophosphate dehydrogenase 2 (IMPDH 2) transcript as the target enzyme of mycophenolic acid (MPA) pathway, MMF cannot exert its effect.

2. Based on a high enzyme activity of IMPDH 2 a higher MMF dose than in the conventional regimens is needed.

To study the significance of these possible explanations there are 4 objectives in this study:

Objective 1: Since there are no data on SNPs with functional relevance in IMPDH 2 transcript, we will first sequence all 14 exons of this gene in their entirety in 100 gender and age matched healthy individuals.

Objective 2: The functional relevance of a detected SNP will be tested in vitro in a lymphocyte proliferation assay using various MPA concentrations.

Objective 3: These functionally relevant SNPs will be searched in patients with kidney graft in a retrospective as well as prospective manner.

Objective 4: Parallel to the genotyping experiments, IMPDH 2 activity and MPA plasma levels will be measured in all patients recruited in the study prospectively.

An association between these SNPs or various IMPDH 2 activity / MPA plasma levels with MMF responsiveness will be examined.

Objective 5: Strongyloides IgG titers are screened to evaluate the prevalence of helminth carriers in patients with immunosuppressive therapy.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00978965
Study type Observational
Source Medical University of Vienna
Contact
Status Completed
Phase
Start date October 2009
Completion date September 9, 2020
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06026592 - Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
Active, not recruiting NCT02444429 - 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation Phase 3
Completed NCT02238418 - Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria. Phase 4
Completed NCT01729494 - Belatacept Early Steroid Withdrawal Trial Phase 4
Terminated NCT01436305 - Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation Phase 2
Completed NCT02843295 - Catalytic Antibodies to Predict Uninvasively Late Transplant Failure N/A
Terminated NCT01276834 - Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation Phase 4
Completed NCT00842699 - Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab N/A
Completed NCT00525681 - Interaction Between Rimonabant and Cyclosporine and Tacrolimus Phase 4
Completed NCT00776750 - Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients Phase 4
Completed NCT00189735 - A Study to Evaluate FK778 in Kidney Transplant Patients Phase 2
Recruiting NCT04052867 - Intravenous Lignocaine Infusion in Laparoscopic Donor Nephrectomy N/A
Recruiting NCT03114826 - Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients N/A
Completed NCT02587052 - A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis, GenTac
Completed NCT02020642 - Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx) N/A
Completed NCT01435291 - AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation Phase 4
Recruiting NCT01001065 - Association of the Intrarenal Resistance Index (RI) of Transplanted Kidneys With Generalized Atherosclerosis N/A
Recruiting NCT00903188 - Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation Phase 4
Completed NCT00400400 - Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance Phase 4
Completed NCT00419575 - Renal Transplantation With Immune Monitoring N/A