The goal of this study is to find out which B-cell inhibitor results in the best reduction of anti A/B antibody levels at which time interval, to make the best choice for a particcular drug in the desensitization treatment in patients receiving an…
ID
Source
Brief title
Condition
- Haematological disorders NEC
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The dynamics of the anti A/B titer in time of three different B cell-inhibitors
(rituximab, bortezomib, alemtuzumab).
Secondary outcome
effect of blood transfusions on the anti A?B titers.
Background summary
Because of a shortage of cadaveric donororgans for transplantation, nowadays
more kidneys from living donors are used. Since recent years also
ABO-incompatible transplantations are performed. The anti A or B antibodies in
the recipient in this case could result in hyperacute rejection. This involves
B-cells that produce the antibodies and might fulfill other immunogenic roles.
To prevent rejection, desensitisation procedures are performed, which are done
by plasmapheresis, IVIG, ATG and antigen-specific immune absorption in
combination with immune suprresive drugs. In the LUMC ABO-incompatible
kidneytransplants are performed since 2010 and patients are pretreated with
B-cell inhibitors after which remaining anti A/N antibodies are removed bij
plasma exchange and/or immune absoprtion procedures. Three different B-cell
inhibitors are used. Thus far it is unclear which drug results in optimal
decrease of anti A/B antibodies.
Study objective
The goal of this study is to find out which B-cell inhibitor results in the
best reduction of anti A/B antibody levels at which time interval, to make the
best choice for a particcular drug in the desensitization treatment in patients
receiving an ABO-incompatible transplant.
Study design
In patients that are treated with one of the three B-cell inhibitors
(rituximab, bortezomib, alemtuzumab) with or without chemotherapy, an EDTA tube
of blood is withdrawn at start of this treatment and before every new cycle of
treatment (weekly up to 4-weekly till a maximum of 8 times). The bllod will be
taken in addition to regular blood test. The serum is frozen on the
bloodtrasfusion department and at later timepoints the anti A/B levels of the
collected samples are measured. This will result in different kinetica of anti
A/B titers in time of the three different drugs.
Study burden and risks
The burden for the patient participating in this study will be an extra 8 ml
bloodwithdrawal during a regular withdrawal (patients do not have to undergo an
extra venapuncture). This extra blood tube will be collecte up to a maximum of
8 times in a period of 24-32 weekstime (dependent on their treatment scheme).
This will not induce a risk for the patient. The induction of anemia is thought
to be unrelevant to the patient.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
age * 18 yr
patients should be competent
have blood group A,B or O
will receive treatment with rituximab, bortezomib, alemtuzumab (prescribed by their hematologist)
Exclusion criteria
blood group AB
having a low antiA/B titer < 1:8
treatment with IVIG or plasma in the past three months
Design
Recruitment
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 |
|---|---|
| CCMO | NL41978.058.12 |