Last reviewed · How we verify
Physioneal 40
Physioneal 40 is a peritoneal dialysis fluid that facilitates ultrafiltration and solute removal in patients with renal failure by creating an osmotic gradient across the peritoneal membrane.
Physioneal 40 is a peritoneal dialysis fluid that facilitates ultrafiltration and solute removal across the peritoneal membrane during peritoneal dialysis treatment. Used for End-stage renal disease requiring peritoneal dialysis.
At a glance
| Generic name | Physioneal 40 |
|---|---|
| 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 / Renal replacement therapy |
| Phase | FDA-approved |
Mechanism of action
Physioneal 40 is a balanced peritoneal dialysis solution containing 40 mmol/L of bicarbonate buffer and lactate, designed to reduce peritoneal inflammation and improve biocompatibility compared to conventional dialysates. The solution uses glucose as the osmotic agent to drive fluid removal while the buffering system helps maintain peritoneal pH and reduce glucose degradation products that can accumulate during dwell time.
Approved indications
- End-stage renal disease requiring peritoneal dialysis
Common side effects
- Peritonitis
- Abdominal pain
- Hyperglycemia
- Electrolyte imbalances
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 |