Improving the removal of toxic substances in the blood by two different forms of peritoneal dialysis (a treatment for patients with chronic kidney disease with intraabdominal fluid exchange to remove fluid and toxic substances from the blood whereby the peritoneal membrane serves as a filter).

IMProving Ultrafiltration and REmoval of uremic toxins by adapted automated peritoneal dialysis in a single center study (IMPURE-Study). - Impure-Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004176-22-AT

Enrollment

Registered

2017-01-27

Start date

2017-04-28

Completion date

Unknown

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease G5D

Interventions

Trade Name: balance 1,5% Glucose, 1,25mmol/l Calcium, Peritonealdialyselösung Product Name: balance 1,5% Glucose, 1,25mmol/l Calcium, Peritonealdialyselösung Pharmaceutical Form: Solution for peritone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Male and female probands aged between 18 – 85 years •Written consent of the participant after being informed •PD treatment for at least 3 months •Stable on PD for at least 3 months •Peritonitis-free for at least 3 months 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 11 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11

Exclusion criteria

Exclusion criteria: • Known intolerance/hypersensitivity against “balance Peritonealdialyselösungen” • Purification parameters known to be below K/DOQI recommended value of a minimum total Kt/Vurea of 1.7 • Current involvement in another clinical trial • Pregnancy or breast-feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to evaluate ultrafiltration by an adapted automated peritoneal dialysis regime (APD-A) in comparison to a conventional automated peritoneal dialysis regime (APD-C). ;Secondary Objective: Secondly the study wants to evaluate the removal of uremic toxins comparing APD-A and APD-C measuring peritoneal Kt/V urea and peritoneal creatinine clearance; plasma beta-2-microglobulin, phosphate dialytic removal, sodium dialytic removal, blood pressure; dosage of erythropoiesis-stimulating agents;;Primary end point(s): Ultrafiltration;Timepoint(s) of evaluation of this end point: 24 weeks	—

Measure

Time frame

Main Objective: The aim of the study is to evaluate ultrafiltration by an adapted automated peritoneal dialysis regime (APD-A) in comparison to a conventional automated peritoneal dialysis regime (APD-C). ;Secondary Objective: Secondly the study wants to evaluate the removal of uremic toxins comparing APD-A and APD-C measuring peritoneal Kt/V urea and peritoneal creatinine clearance; plasma beta-2-microglobulin, phosphate dialytic removal, sodium dialytic removal, blood pressure; dosage of erythropoiesis-stimulating agents;;Primary end point(s): Ultrafiltration;Timepoint(s) of evaluation of this end point: 24 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): peritoneal Kt/V urea and peritoneal creatinine clearance; plasma beta-2-microglobulin, phosphate dialytic removal, sodium dialytic removal, blood pressure; dosage of erythropoiesis-stimulating agents;;Timepoint(s) of evaluation of this end point: 24 weeks	—

Countries

Austria

Contacts

Public ContactAnna Goritschan (Subinvestigator)

Klinische Abteilung für Nephrologie, Medizinische Universität Graz

anna.goritschan@medunigraz.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026