Phase 4
N=7
Ertapenem Pharmacokinetics in Patients in Continuous Ambulatory Peritoneal Dialysis
Continuous Ambulatory Peritoneal Dialysis · End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT00939952 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Volume of Distribution, Central Compartment (Vc) — 2.78 Liters (L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ertapenem (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albany College of Pharmacy and Health Sciences
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Volume of Distribution, Central Compartment (Vc) |
2.78 | — |
| PRIMARY Clearance (CL) |
.24 | — |
| PRIMARY k12 |
2.51 | — |
| PRIMARY k21 |
2.03 | — |
| PRIMARY k13 |
0.082 | — |
| PRIMARY k31 |
.16 | — |
| PRIMARY Residual Drug in Peritoneal Cavity After 1st Exchange |
.64 | — |
Summary
The objective of this study is to characterize the pharmacokinetic profile of ertapenem during continuous ambulatory peritoneal dialysis (CAPD).
Eligibility Criteria
i. Inclusion criteria Adult patients (≥ 18 years), non-infected (afebrile, lack of constitutional symptoms and no leukocytosis), on a stable PD regimen (at least one month) are eligible for participation. Both patients with and without residual renal function will be studied. Non-anuric patients concurrently receiving medications with the potential to inhibit active tubular secretion will be allowed to enter the study after a 2-week washout period. These medications include H2-antagonists, trimethoprim, or probenecid. The patient and their physician at the Hortense and Louis Rubin Dialysis Center will contacted if any medication needs to be discontinued.
ii. Exclusion criteria Patients will be ineligible for the study if they have had peritonitis within the previous 4 weeks, clinical signs or symptoms of active infection, elevated white blood cell count, or treatment with any antibiotic within the previous 2 weeks. Patients with a hemoglobin (hgb) < 11 g/dL will be ineligible for study inclusion. Patients with stated or documented allergies to beta-lactams medications will not be eligible. Pregnant or breastfeeding women will not be eligible for inclusion. All women of child-bearing age will need to yield a serum hCG ≤ 5 mIU/mL within 2 weeks of the scheduled study day. Patients taking valproic acid will also be excluded.
Data sourced from ClinicalTrials.gov (NCT00939952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.