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Physioneal 35
Physioneal 35 is a peritoneal dialysis fluid formulated to optimize electrolyte balance and reduce peritoneal membrane injury during dialysate exchange.
Physioneal 35 is a peritoneal dialysis fluid formulated to optimize electrolyte balance and reduce peritoneal membrane injury during dialysate exchange. Used for Peritoneal dialysis in end-stage renal disease (ESRD).
At a glance
| Generic name | Physioneal 35 |
|---|---|
| Also known as | Nephropaed-PD-01/B |
| Sponsor | University of Erlangen-Nürnberg Medical School |
| Drug class | Peritoneal dialysis solution |
| Modality | Small molecule |
| Therapeutic area | Nephrology |
| Phase | FDA-approved |
Mechanism of action
Physioneal 35 is a bicarbonate-buffered peritoneal dialysis solution designed to improve biocompatibility compared to conventional lactate-buffered solutions. It contains a physiologic electrolyte composition and uses bicarbonate as the primary buffer, which reduces glucose degradation products and advanced glycation end products (AGEs) that can damage the peritoneal membrane. This formulation aims to preserve peritoneal function and reduce inflammation during long-term peritoneal dialysis treatment.
Approved indications
- Peritoneal dialysis in end-stage renal disease (ESRD)
Common side effects
- Peritonitis
- Hyperglycemia
- Electrolyte imbalances
- Abdominal discomfort
Key clinical trials
- Efficacy and Safety of XyloCore Peritoneal Dialysis Solution. (PHASE3)
- IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients (PHASE4)
- IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients (PHASE3)
- Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Protein Metabolism (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |