Minimization of maintenance immunosuppression early after renal transplantation.

Minimization of maintenance immunosuppression early after renal transplantation to prednisolone and everolimus is effective.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22724

Enrollment

270

Registered

2009-01-06

Start date

2005-01-01

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

renal transplantation, renal failure ciclosporin, allograft nephropathy, everolimus, mycophenolate mofetyl. Niertransplantatie, ciclosporine, cardiovasculaire bijwerkingen

Interventions

The effects of longtime maintenance therapy with everolimus or with MPS in combination with prednisolone will be evaluated. Both drugs will be given orally. Dosages will be guided by calculating drug

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients, between the age of 18 en 70 years, receiving a first or second renal transplant; 2. Patients had to understand the purpose and risks of the study; 3. Patients had to give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with a HLA-identical sibling donor; 2. a third or a fourth transplant; 3. current or historical panel reactive antibodies of more than 50%; 4. female patients unwilling to use adequate contraception during the study; 5. a cholesterol > 8.5 mmol/l despite HMG co-A reductase inhibition.

Design outcomes

Primary

Measure	Time frame
The degree of inflammation and fibrosis and the degree of arteriolar hyalinosis in renal biopsies taken at 6 and 24 months after implantation. Biopsies will be evaluated according to the Banff ‘97 Criteria for Renal Allograft Biopsy Interpretation (appendix II). Quantitative morphometric analysis of interstitial fibrous tissue will be performed using the digital image analysis technique	—

Secondary

Measure	Time frame
1. Cardiovascular (surrogate) endpoints; IMT Intima/Media Thickness of the a. carotis interna; 2. Blood pressure and the number of antihypertensives; 3. Lipid profile; 4. Renal allograft survival and function (Nankivell), and patient survival; 5. The incidence of malignancies; 6. Infectious complications; 7. Miscellaneous; fasting glucose, HbA1c, uric acid MPA-levels and IMPDH activity over time, everolimus levels. MPA and everolimus levels over time (AUCs) will be correlated to graft function, rejection episodes and trough levels.	—

Measure

Time frame

1. Cardiovascular (surrogate) endpoints; IMT Intima/Media Thickness of the a. carotis interna; 2. Blood pressure and the number of antihypertensives; 3. Lipid profile; 4. Renal allograft survival and function (Nankivell), and patient survival; 5. The incidence of malignancies; 6. Infectious complications; 7. Miscellaneous; fasting glucose, HbA1c, uric acid MPA-levels and IMPDH activity over time, everolimus levels. MPA and everolimus levels over time (AUCs) will be correlated to graft function, rejection episodes and trough levels.

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Contacts

Public ContactF. Bemelman

Academic Medical Center (AMC), Renal Transplant Unit, P.O. Box 22660

+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)