This study has been transitioned to CTIS with ID 2024-515480-66-01 check the CTIS register for the current data. To attenuate the impact and duration of delayed graft funtion by dampening schemia reperfusion injury
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Difference between treatment and placebo group in duration of
delayed graft failure (DGF). DGF is defined as need for dialysis,
excluding short sessions for hyperkalemia. DGF is defined as need for
dialysis, excluding single sessions for hyperkalemia.
Secondary outcome
- Mean duration of hospitalization after kidney transplantation
- Incidence of persistent dialysis DGF (> 14 days)
- Incidence of DGF using functional and dialysis definition and a
combination of the two
- 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
Background summary
Delayed graft function (DGF) is a growing problem as more kidneys from deceased
donors are used in transplantation procedures. DGF is caused in part by
ischemia reperfusion injury (IRI). Alkaline phosphatase can dephosphorylate
toxic adenosine triphosphate which is a big contributer to the extent of IRI.
This could lead to less kidney damage and better graft function.
Study objective
This study has been transitioned to CTIS with ID 2024-515480-66-01 check the CTIS register for the current data.
To attenuate the impact and duration of delayed graft funtion by dampening
schemia reperfusion injury
Study design
randomized double blind placebo-controlled trial
Intervention
30,000IU of bRESCAP or placebo
Study burden and risks
- Alkaline phosphatase has the potential to dampen the damage caused by
impaired perfusion of the kidney. Supplementation could thereby possibly reduce
the impact of ischemia reperfusion injury (IRI) in transplantation surgery.
- There are many pathophysiologic similarities between acute kidney injury
(AKI) and kidney damage in transplantation surgery. IRI and harmful immune
response play a large role in AKI of any cause, studying the effects of
alkaline phosphatase in transplantation surgery could lead to the improvement
of therapeutic options for all AKI patients.
- Previous trials in sepsis AKI patients have shown a beneficial effect of
exogenous alkaline phosphatase on kidney function and mortality. It is possible
that this effect will be observed in transplant patients as well.
- Kidney transplant patients receive double intravenous access as standard of
care, study medication can be administered over one of these access sites.
Also, daily venipunctures are part of standard of care. Thus, there is no need
for extra invasive procedures.
- There is a small risk that this protein-based drug will cause an allergic
reaction. However, since the study drug made form bovine protein, all patients
will be desensitized due to consumption of dietary bovine
proteins. Vegans and strict vegetarians will be excluded from this trial.
- No specific adverse effects of exogenous AP were observed in previous trials
and the number and severity of adverse effects were similar when compared to
placebo.
- Addition to total fluid load will not be a problem since total extra infusion
during the 3 day treatment period will be 150ml.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Age > 18
- Recipients of a donor awaiting cardiac death on the intensive care
(definition of a donor cardiac death type III according to the *Maastricht
classification*)
- Written informed consent
Exclusion criteria
- Strict vegetarians or vegans
- History of allergy to bovine proteins
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-515480-66-01 |
| EudraCT | EUCTR2021-006767-14-NL |
| CCMO | NL79196.018.22 |