AMC-DRIP

Desensitization of highly pre-sensitized dialysis patients waiting for kidney transplantation by Rituximab, IVIG-L and rescue Plasmapheresis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26482

Enrollment

Registered

2007-06-19

Start date

2007-07-15

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Highly sensitized renal transplant recipients, desensitization, high PRA, kidney transplantation. Hoog gesensibiliseerde niertransplantatie patienten, desensibilisatie, hoge PRA, niertransplantatie

Interventions

In vivo administration of Rituximab (two doses): The first dose of Rituximab (MabThera, Roche) 375 mg/m2 will be administered intravenously five months prior to the transplantation. The second and las

if there are no adverse side effects

increase the rate 50 mg/hour every 30 minutes, to a maximum of 400 mg/hour. Subsequent infusions: Start at 100 mg/hour

if it is safe

increase the rate 100 mg/hour every 30 minutes, to a maximum of 400 mg/hour. All recipients will be given acetaminophen (1000 mg) and Di-adresoneF (25 mg), tavegil (2 mg), 30 min before the infusion.

Eligibility

Inclusion criteria

Inclusion criteria: Patients older than 18 years with end stage renal failure and a current PRA higher than 80 % who are for more than two years on the waiting list for a cadaveric donor kidney, and included in the AM program. Only heart beating donors will be accepted.

Exclusion criteria

Exclusion criteria: A. Complete IgA deficiency B. Overhydration C. History of anaphylaxis against blood/plasma products D. Significant cardiac or pulmonary disease, hepatitis C or HIV infection, or malignancy within the last 5 years

Design outcomes

Primary

Measure	Time frame
Primary end point is achievement of a negative cross-match test with the donor kidney and transplantability.	—

Secondary

Measure	Time frame
Secondary objectives are 1. Patient and graft survival; 2. Graft function as assessed by calculated creatinine clearance, proteinuria, the number and severity of acute (antibody mediated) rejections, blood pressure (antihypertensive treatment), monitoring of infections and the occurrence of malignancies.	—

Contacts

Public ContactAjda T. Rowshani

Academic Medical Center Department of Internal Medicine, F4-215 PO Box 22700

T.Rowshani@amc.nl+31-20-5663365 page 58816

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)