Identification of patients with high probability of not or poorly responding to therapy with mycophenolic acid pro-drugs.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014997-16-AT

Enrollment

150

Registered

2009-10-21

Start date

2010-04-08

Completion date

Unknown

Last updated

2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with a de novo kidney transplantation MedDRA version: 12.0 Level: LLT Classification code 10023438 Term: Kidney transplant

Interventions

Trade Name: Myfortic Product Name: Mycophenolate sodium Pharmaceutical Form: Coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: de novo kidney graft Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: highly immunized patients (due to previous transplantations etc) with PRA levels >40%

Design outcomes

Primary

Measure	Time frame
Main Objective: Detection of functionally relevant SNPs in IMPDH 2 gene.;Secondary Objective: The association of detected SNPs in inosine monophosphate dehydrogenase-2 transcript or high IMPDH 2 activity with biopsy proven rejection reactions in the first year after transplantation.;Primary end point(s): Biopsy proven rejection	—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026