Trial to investigate the impact of haemodialysis before transplant surgery on early kidney allograft function

Randomised controlled trial evaluating the effect of haemodialysis applied before transplant surgery on early renal allograft function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN07061584

Enrollment

220

Registered

2009-04-20

Start date

2003-07-02

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Kidney allograft function Urological and Genital Diseases Disorders resulting from impaired renal tubular function

Interventions

Based on pre-transplant levels of serum potassium (a concentration greater than 5.0 mEq/L is regarded as a requirement for pre-operative dialysis) patients are randomly assigned to one of two separate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult (aged 18 years and over) male or female end-stage renal disease patients on maintenance haemodialysis anticipating deceased donor kidney allotransplantation.

Exclusion criteria

Exclusion criteria: 1. Aged less than 18 years 2. Pre-emptive kidney transplantation 3. Non-heart-beating donor transplantation 4. Combined organ transplantation 5. Continuous ambulatory peritoneal dialysis as maintenance renal replacement therapy 6. Symptomatic fluid overload necessitating pre-operative ultrafiltration 7. Presensitised patients subjected to peri-transplant immunoadsorption for desensitisation 8. Patients subjected to haemodialysis less than 16 hours before randomisation

Design outcomes

Primary

Measure	Time frame
Estimated glomerular filtration rate (eGFR) at day 5 post-transplantation calculated according to the reexpressed Modification of Diet in Renal Disease (MDRD) study equation.	—

Secondary

Measure	Time frame
1. eGFR according to the Mayo Clinic equation at day 5 2. Serum creatinine level at day 5 3. Delayed graft function (need for dialysis within the first post-transplant week) 4. Slow graft function (definition: serum creatinine greater than 3 mg/dL on post-operative day 5 without requiring dialysis) 5. Acute biopsy-proven cell-mediated allograft rejection within the first three months 6. Acute C4d-positive graft dysfunction within the first three months 7. One-year actuarial death-censored graft survival	—

Measure

Time frame

1. eGFR according to the Mayo Clinic equation at day 5 2. Serum creatinine level at day 5 3. Delayed graft function (need for dialysis within the first post-transplant week) 4. Slow graft function (definition: serum creatinine greater than 3 mg/dL on post-operative day 5 without requiring dialysis) 5. Acute biopsy-proven cell-mediated allograft rejection within the first three months 6. Acute C4d-positive graft dysfunction within the first three months 7. One-year actuarial death-censored graft survival

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Countries

Austria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026