NCT00978965

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2020

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

10.9 years

First QC Date

September 14, 2009

Last Update Submit

September 9, 2020

Conditions

Renal Transplantation

Keywords

kidney transplantationimmunosuppressionsingle nucleotide polymorphismIMPDH

Outcome Measures

Primary Outcomes (2)

  • Detection of functionally relevant SNPs in IMPDH 2 gene.

    6 months

  • The association of detected SNPs in inosine monophosphate dehydrogenase-2 transcript or high IMPDH 2 activity with the lack of response to MPA therapy defined as - number of biopsy proven acute rejections in the first year after transplantation

    12 months per patient

Secondary Outcomes (1)

  • Screening for strongyloides IgG titers

    12 months

Study Arms (1)

All patients

Genetic: MPA SNP

Interventions

MPA SNPGENETIC

Functional relevant MPA SNP will be sought in patients DNA isolated from leucocytes

All patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a de novo kidney transplantation

You may qualify if:

  • patients with a de novo kidney graft and age \>18 and \< 75

You may not qualify if:

  • pregnancy
  • panel of antigens reactivity \> 40%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine III, Division of Nephrology

Vienna, A-1090, Austria

Location

Study Officials

  • Gürkan Sengölge, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Priv.-Doz. Dr.

Study Record Dates

First Submitted

September 14, 2009

First Posted

September 17, 2009

Study Start

October 1, 2009

Primary Completion

September 9, 2020

Study Completion

September 9, 2020

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations

AU(1)