Novel maintenance Immunosuppression with Controlled systemic Exposure.

Prospective, open label, randomized multicenter study to compare AUC-monitored withdrawal of either cyclosporine (Neoral) or mycophenolate mofetil (MMF) in stable renal transplant recipients on a triple regimen with Neoral, MMF and steroids.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27195

Enrollment

100

Registered

2005-09-15

Start date

2003-01-01

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

Stable renal transplant recipients.

Interventions

Randomized, controlled, prospective multicenter study in stable renal transplant recipients, at least 6 months post-transplantation, who receive maintenance immunosuppressive treatment with cyclospori

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients, 18 years or older, on maintenance therapy with Neoral, MMF and steroids; 2. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Calculated creatinine clearance £ 20 ml/min; 2. Multi-organ recipients; 3. Patients with an (historic) PRA >60%; 4. Vascular type rejection in the past; 5. Patients with more than two acute rejection episodes in the past; 6. Third renal transplant or more; 7. Patients receiving other investigational drugs than MMF in combination with Neoral; 8. Metastatic neoplasms, post-transplant lymfoproliferative disease.

Design outcomes

Primary

Measure	Time frame
1. Composite of Graft function, - incidence of acute rejection episodes; 2. Graft and patient survival.	—

Secondary

Measure	Time frame
Non-immune toxicity 1. Hypertension; 2. Hyperlipedimia; 3. Gout, uric acid; 4. Magnesium; 5. Nausea, dyspepsia, diarrhea; 6. Anemia/Leukopenia/Thrombopenia; 7. Infections (clinically defined); 8. Post-transplant lympho-proliferative disease; 9. Malignancy.	—

Contacts

Public ContactJ.W. Fijter, de

Leiden University Medical Center (LUMC), Department of Nephrology, C3-P22, P.O. Box 9600

jwdefijter@lumc.nl+31 (0)71 5262169

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)