Eurotransplant Senior DR-compatible Program

Eurotransplant Senior DR-compatible Program - ESDP

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38038

Enrollment

Registered

2009-02-24

Start date

2010-01-01

Completion date

Unknown

Last updated

2024-09-30

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

Conditions

niertransplantatie kidney transplantation renal replacement therapy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients > 64 years of age Placed on the Eurotransplant Kidney Waiting List

Exclusion criteria

Exclusion criteria: • Active systemic infection; • HIV (antigen or antibody), hepatitis B (HBsAg), or hepatitis C (antibody) positivity; • History of malignancy within five years of enrolment (with the exception of adequately treated non-melanoma skin cancer); • Known to be poorly compliant with clinic visits or prescribed medication; • Medical history that might limit the individual*s ability to take the defined immunosuppressive agents.

Design outcomes

Primary

Measure	Time frame
The primary comparison will involve an intention-to-treat analysis of • Incidence of biopsy-proven acute rejection (BPAR) 6 months post-transplantation • Incidence of steroid-resistant and recurrent acute rejection (requiring antibody therapy)	—

Secondary

Measure	Time frame
All secondary assessments will be conducted amongst the entire study population, and will be of the effects of initial allocation (with or without matching for HLA-DR) on safety outcomes and efficacy measures: •Primary non function (PNF); delayed graft function (DGF, defined by dialysis requirement within 7 days post transplant or spontaneous decrease of serum creatinine >10% per day for 3 consecutive days occurring beyond the seventh day post transplant) •Graft function at month 3, 6, 12 and yearly up to 5 years (calculated GFR, using the Modified Diet in Renal Disease [MDRD] equation). •Incidence of Late Acute rejection (BPAR occurring between month 6 and 12); •Presence of donor specific antibodies (DSA) at 6 months (ETRL), these sera will also be used to calibrate for differences in the creatinine assays. •Graft survival (including cause of graft loss); •Patient survival (including cause of death); •Incidence of cardiovascular events (sudden death, PTCA, CABG, non-fatal acute myocardial infarction, CVA, peripheral vascular disease); •Incidence of infections (sub-classified as mild, serious and life threatening); •Incidence of malignancy (including post-transplantation lymphoproliferative disorder); •Incidence of anaemia, leukopenia, thrombocytopenia as well as comparison of median values of haemoglobin, white cell count and platelet count); •Blood pressure (assessed by readings at clinic visits, use of antihypertensive medication); •Number of days in hospital during index admission and total in the first year, excluding admission or scheduled surgery for non-transplant related medical issues; •Subset analyses based on waiting-time; cold ischemia time; HLA-DR compatibility; donor and/or recipient age >= 70 years.	—

Measure

Time frame

All secondary assessments will be conducted amongst the entire study population, and will be of the effects of initial allocation (with or without matching for HLA-DR) on safety outcomes and efficacy measures: •Primary non function (PNF); delayed graft function (DGF, defined by dialysis requirement within 7 days post transplant or spontaneous decrease of serum creatinine >10% per day for 3 consecutive days occurring beyond the seventh day post transplant) •Graft function at month 3, 6, 12 and yearly up to 5 years (calculated GFR, using the Modified Diet in Renal Disease [MDRD] equation). •Incidence of Late Acute rejection (BPAR occurring between month 6 and 12); •Presence of donor specific antibodies (DSA) at 6 months (ETRL), these sera will also be used to calibrate for differences in the creatinine assays. •Graft survival (including cause of graft loss); •Patient survival (including cause of death); •Incidence of cardiovascular events (sudden death, PTCA, CABG, non-fatal acute myocardial infarction, CVA, peripheral vascular disease); •Incidence of infections (sub-classified as mild, serious and life threatening); •Incidence of malignancy (including post-transplantation lymphoproliferative disorder); •Incidence of anaemia, leukopenia, thrombocytopenia as well as comparison of median values of haemoglobin, white cell count and platelet count); •Blood pressure (assessed by readings at clinic visits, use of antihypertensive medication); •Number of days in hospital during index admission and total in the first year, excluding admission or scheduled surgery for non-transplant related medical issues; •Subset analyses based on waiting-time; cold ischemia time; HLA-DR compatibility; donor and/or recipient age >= 70 years.

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Countries

Netherlands

Outcome results