End stage renal disease under treatment with peritoneal dialysis
Conditions
Interventions
Trade Name: Emend
Product Name: Emend
Product Code: EMEA/H/C/000527
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Emend
Other descriptive name: APREPITANT
Concentration unit: mg milligram(s)
Sponsors
University of Gothenburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Included persons are treated with PD since at least 3 months and are males aged 20-90 or post-menopausal females up to age 90. Included persons must have positive ultrafiltration (ultrafiltration volume larger than 0 ml/24 hours measured not more than one month earlier). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: Moderate to serious liver damage, potential or known damage to the blood-brain barrier (e.g. brain tumor, meningitis, encephalitis), peritonitis during the last two months and treatment with any of the following drugs: warfarin, corticosteroider, pimozid, terfenadin, astemizol, cisaprid, ciklosporin, takrolimus, sirolimus, everolimus, alfentanil, diergotamin, ergotamin, fentanyl, kinidin, rifampicin, fenytoin, karbamazepin, fenobarbital och metotrexat.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In an earlier study in rats we demonstrated that experimental peritoneal dialysis (PD) induced a neurogenic inflammatory response in the peritoneum, leading to the release of neuropeptides substance P (SP) and CGRP. By blocking the effects of SP (NK1 receptor blockade) we were able to reduce plasma protein loss (leakage of albumin from blood to the peritoneal cavity) by half. Our primary hypothesis is that NK1 receptor blockade has corresponding effects in humans and thus substantially reduces loss of plasma albumin during dialysis.;Secondary Objective: Secondary objectives involve other known effects of neuropeptide release. Substance P propagates an inflammatory response by inducing the release of inflammatory cytokines. Hypothetically NK1 receptor blockade will also inhibit this effect, thereby reducing the negative long-term effects of PD on peritoneal structure and function.;Primary end point(s): Measurements are performed according to the PDC (Personal Dialysis Capacity) protocol whis is a clinical routine applied to PD patients. PDC quantitates the transperitoneal transport of water and solutes, including proteins, during dialysis in terms of the three-pore model. In addition, concentrations of the cytokines IL-1 beta, IL-6, IL-8, TNF alfa, NGF are measured in plasma and dialysate. Primary end points are transperitoneal albumin transport and peritoneal release of IL-1 beta, IL-6, IL-8, TNF alfa, NGF.;Timepoint(s) of evaluation of this end point: Transperitoneal albumin transport is evaluated as part of the PDC evaluation within two weeks after the finalization of each treatment time period. Evaluations of intraperitoneal cytokine release are performed whenever measurements of pooled samples are available, typically every three to six months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points are the other measurements obtained from the PDC, i.e. peritoneal diffusion surface area, hydraulic conductivity and reabsorption.;Timepoint(s) of evaluation of this end point: PDC evaluation is performed within two weeks after the finalization of each treatment time period. | — |
Countries
Sweden
Contacts
Public ContactInstitute of Biomedicine
University of Gothenburg
Outcome results
None listed