Alkaline Phosphatase as treatment of Ischemia Reperfusion Injury to prevent delayed graft function

Conditions

End stage kidney disease - Kidney transplantation donors receiving kidneys from donation after circulatory death (DCD).

Brief summary

Difference between treatment and placebo group in delayed graft function (DGF) duration (in days) as measured on day 28. DGF is defined as need for dialysis within 7 days after transplantation, excluding single sessions for hyperkalemia. No need for dialysis will be registered as 0 days.

Detailed description

Mean duration of hospitalization after kidney transplantation, Incidence of persistent dialysis DGF (> 14 days), Incidence of functional and dialysis DGF, Duration of DGF using functional and dialysis definition and a combination of the two, Dall of serum creatinine in the first week after transplantation, Kidney perfusion contrast renography at day 6, Creatinine clearance at 3 months and 1 year after transplantation, Proteinuria at 3 months and 1 year after transplantation, Estimated renal glomerular filtration rate (eGFR) calculated with MDRD and the CKD-epi formula at 3 months and 1 year after transplantation, Primary non-function (defined as dialysis dependency or creatinine clearance <20ml/min at 3 months)., Incidence of biopsy proven rejection within one year follow-up period., All-cause mortality at day 28 and 90 and 1 year.

Related papers

No related papers found yet.

Interventions

DRUGbRESCAP

DRUG0.9% sodium chloride (nacl

DRUGsaline) is given as placebo. sodium chloride (0.9% nacl) is provided by the trial pharmacy of amsterdamUmc and is from baxter b.v. We have attached the most recent smPC from Baxter N.V. regarding the sodiumchloride 0.9%.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Difference between treatment and placebo group in delayed graft function (DGF) duration (in days) as measured on day 28. DGF is defined as need for dialysis within 7 days after transplantation, excluding single sessions for hyperkalemia. No need for dialysis will be registered as 0 days.	—

Secondary

Measure	Time frame
Mean duration of hospitalization after kidney transplantation, Incidence of persistent dialysis DGF (> 14 days), Incidence of functional and dialysis DGF, Duration of DGF using functional and dialysis definition and a combination of the two, Dall of serum creatinine in the first week after transplantation, Kidney perfusion contrast renography at day 6, Creatinine clearance at 3 months and 1 year after transplantation, Proteinuria at 3 months and 1 year after transplantation, Estimated renal glomerular filtration rate (eGFR) calculated with MDRD and the CKD-epi formula at 3 months and 1 year after transplantation, Primary non-function (defined as dialysis dependency or creatinine clearance <20ml/min at 3 months)., Incidence of biopsy proven rejection within one year follow-up period., All-cause mortality at day 28 and 90 and 1 year.	—

Measure

Time frame

Mean duration of hospitalization after kidney transplantation, Incidence of persistent dialysis DGF (> 14 days), Incidence of functional and dialysis DGF, Duration of DGF using functional and dialysis definition and a combination of the two, Dall of serum creatinine in the first week after transplantation, Kidney perfusion contrast renography at day 6, Creatinine clearance at 3 months and 1 year after transplantation, Proteinuria at 3 months and 1 year after transplantation, Estimated renal glomerular filtration rate (eGFR) calculated with MDRD and the CKD-epi formula at 3 months and 1 year after transplantation, Primary non-function (defined as dialysis dependency or creatinine clearance <20ml/min at 3 months)., Incidence of biopsy proven rejection within one year follow-up period., All-cause mortality at day 28 and 90 and 1 year.

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Countries

Netherlands

Outcome results

None listed