In this pilot study, we are setting on to investigate the differential effects of the VDR activator paricalcitol versus calcitriol on peritoneal transport, peritoneal inflammation and peritoneal defense parameters in PD patients.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Verstoring peritoneale homeostase door peritoneaaldialyse
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endpoints are differences (25% or more) in markers of inflammation and
peritoneal transport between the paricalcitol and alphacalcidol groups.
Secondary outcome
None
Background summary
Because of survival benefit, vitamine D receptor activators (VDR) are routinely
prescribed to (peritoneal) dialysis patients. Peritoneal dialysis has a poor
technique survival, due ultrafiltration failure and peritoneal infections. In
all causes of technique failure, the bioincompatible composition of PD-fluids
is considered to be involved. Both neoangiogenesis, impaired wound healing by
mesothelial cells, and hampered peritoneal defence of monocytes are
intermediates between dialysis fluid administration and technique failure.
Vitamine D has pleitropic effects, a.o. on cell division and maturation.
However, these effects differ among the available vitamin D formulations.
Therefore, it is interesting to evaluate differences in pleiotropic effects of
the (standard) VDR calcitrioland a new VDR paricalcitol.
Study objective
In this pilot study, we are setting on to investigate the differential effects
of the VDR activator paricalcitol versus calcitriol on peritoneal transport,
peritoneal inflammation and peritoneal defense parameters in PD patients.
Study design
Multicenter open-label randomized trial in patients on peritoneal dialysis.
Following informed consent active vitamin D treatment will be stopped for a
wash out period of 6 weeks. Patients using high calcium containing dialysis
fluids (1.75 mmol/l) or low pH fluids (about 5 * 5.5.) are switched low Ca
(1.25 mmol/l) and neutral pH fluids (Balance, Ca 1.25 mmol/l or Physioneal).
During the study, Extraneal is only allowed in case of severe ultrafiltration
problems (UF < 1000 ml/24h with 4 3.86%/4.25% glucose containing exchanges).
Thereafter, the patients are randomized (stratified per centrum) according to
patient number to receive a single-dose paricalcitol capsule of 1 ug or 1
tablet of calcitriol 0.25 ug. Dosage of study medication will be titrated
towards PTH levels between 15 and 30 pmol/l according the KDOQI guidelines.
Intervention
Calcitriol or paricalcitol after a wash-out period (see study design).
Study burden and risks
Hypocalciemia during the washout period, due to the interruption of VDR
therapy. Mild hypercalciemia after the start of VDR therapy.
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
· the patient must provide written consent prior to starting the study
· patients must be over 18 years of age
· patients must have CKD stage 5 and treatment with peritoneal dialysis
· indication for active vitamin D therapy based on prevailing guidelines (after 6 weeks of wash-out)
· Calcium, corrected to albumen, < 2.6 mmol/l (after 6 weeks of wash-out)
· Not expected to receive a living donor transplant < 6 months
Exclusion criteria
· Patients who do not meet the specific inclusion criteria.
· UF < 1000 ml/24h with 4 3.86%/4.25% glucose exchanges or impossibility to stop Extraneal
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 |
|---|---|
| EudraCT | EUCTR2007-004680-21-NL |
| CCMO | NL19381.029.10 |