Steroid free immunosuppression or calcineurin inhibitor minimization after Basiliximab induction therapy in kidney transplantation: Comparison with a standard quadruple immunosuppressive regimen.

Steroid free immunosuppression or calcineurin inhibitor minimization after Basiliximab induction therapy in kidney transplantation: Comparison with a standard quadruple immunosuppressive regimen. - Allegro

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34397

Enrollment

300

Registered

2010-12-15

Start date

2011-06-27

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

rejection renal function

Interventions

Concomitant therapy Concomitant therapy will consist of omeprazol, antihypertensives and atorvastatine when needed. Patients at risk for CMV infection (donor or recipient seropositive) wil receive 6

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria • Female or male, aged between 18 and 70 years. • Recipient of a kidney graft (first or second) from a deceased (heartbeating or non-heartbeating) donor or living (non-HLA identical) donor. • The patient understands the purpose and risks of the study and has given written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Exclusion criteria • Patients with multi-organ transplants • Patients who are receiving a third or fourth transplant. • Patients who have > 50 % (current or historic) panel reactive antibodies. • Female patients who are pregnant or unwilling to use adequate contraception during the study.

Design outcomes

Primary

Measure	Time frame
Primary end-points Renal function parameters, proteinuria and microalbuminuria measured 3, 12 and 24 months after transplantation. Renal function measured by endogenous creatinine clearances, serum creatinine and Nankivell GFR.	—

Secondary

Measure	Time frame
Secondary end-points • Rejection episodes • Graft and patient survival • The degree of tubular atrophy and interstial fibrosis, inflammation plus the degree of arteriolar hyalinosis in renal biopsies taken at 12 and 24 months after transplantation. Biopsies will be evaluated according to the Banff *07 Criteria for Renal Allograft Biopsy Interpretation (appendix II). Quantitative morphometric analysis of interstitial fibrous tissue will be performed using the digital image analysis technique. • Cardiovascular incidents, pulse wave velocity measurements and AGEs skin • Blood pressure (mean of three automated measurements while sitting up) and the number of antihypertensives • Lipid profile • The incidence of malignancies • Infectious complications • Dexa bone densitometry • Miscellaneous; Fasting glucose, oral glucose tolerance, HbA1c, uric acid	—

Measure

Time frame

Secondary end-points • Rejection episodes • Graft and patient survival • The degree of tubular atrophy and interstial fibrosis, inflammation plus the degree of arteriolar hyalinosis in renal biopsies taken at 12 and 24 months after transplantation. Biopsies will be evaluated according to the Banff *07 Criteria for Renal Allograft Biopsy Interpretation (appendix II). Quantitative morphometric analysis of interstitial fibrous tissue will be performed using the digital image analysis technique. • Cardiovascular incidents, pulse wave velocity measurements and AGEs skin • Blood pressure (mean of three automated measurements while sitting up) and the number of antihypertensives • Lipid profile • The incidence of malignancies • Infectious complications • Dexa bone densitometry • Miscellaneous; Fasting glucose, oral glucose tolerance, HbA1c, uric acid

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)