Safety and efficacy of mycophenolate mofetil in pediatric renal transplantation.

Maintenance immunosuppression with mycophenolate mofetil and corticosteroids in pediatric kidney transplantation.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29296

Enrollment

Registered

2006-10-30

Start date

2000-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

None listed

Interventions

Start trial is one year after transplantation. Randomisation between 2 groups: continuing with MMF/Pred or CsA/Pred by withdrawal over 3 months of the 3rd immunosuppressive drug. During the 3 month

Eligibility

Inclusion criteria

Inclusion criteria: All Dutch children, receiving a first kidney transplant after 01-01-2000, treated with initial immunosuppression corticosteroids, MMF and CsA, during the latter part of the study with addition of basiliximab.

Exclusion criteria

Exclusion criteria: 1. Not on triple therapy (Pred/CsA/MMF) at the end of the 1st year; 2. More than one acute rejection episode; 3. Rejection episode being not steroid sensitive; 4. No written informed consent.

Design outcomes

Primary

Measure	Time frame
1. Glomerular filtration rate; 2. Incidence of acute rejections; 3. Serumlipids; 4. Bloodpressure and number of antihypertensive drugs.	—

Secondary

Measure	Time frame
1. Graft survival; 2. Incidence of malignancies; 3. Incidence of viral infections; 4. Incidence of anemia.	—

Contacts

Public ContactKarlien Cransberg

Erasmus Medical Center, Sophia Children's Hospital, Dr Molewaterplein 60

k.cransberg@erasmusmc.nl+31 (0)10 4636363

Outcome results