Clinical trial · Interventional
The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis
NCT01753154CI-TRIAL-00021986completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the biocompatibility of the peritoneal dialysis (PD) solution balance in comparison to the conventional PD solution in APD(automated peritoneal dialysis) patients using the APD cycler sleep•safe.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Renal Failure | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Solution A (conventional PD solution) | Drug | — | UNRESOLVED |
| Solution B (balance PD solution) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Solution B (balance PD solution)
- description
- Treatment 8 weeks with solution B (balance PD solution), next 8 weeks with solution A (conventional PD solution)
- interventionNames
- Drug: Solution B (balance PD solution)
- type
- ACTIVE_COMPARATOR
- label
- Solution A (conventional PD solution)
- description
- Treatment 8 weeks with solution A (conventional PD solution), next 8 weeks with solution B (balance PD solution)
- interventionNames
- Drug: Solution A (conventional PD solution)
Primary outcomes (1)
- measure
- CA 125 (cancer antigen 125) appearance rate in the 24 hours effluent and estimated hydration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * APD patient ≥ 18 years * Prevalent patient with at least 3 months experience on APD prior to inclusion * Patient is trained on and being treated with the sleep•safe APD cycler * Patient treated on APD exclusively with registered conventional PD solutions CAPD 2, CAPD 3, CAPD 4, CAPD 17, CAPD 18 or CAPD 19 for at least 8 weeks prior to inclusion * Patient is on stable diuretic treatment e.g no change in diuretic treatment within the last 30 days prior to inclusion * Informed consent signed and dated by study patient and investigator/authorised physician * Ability to understand the nature and requirements of the study Exclusion Criteria: * Peritonitis treatment £ 4 weeks preceding inclusion * APD patients treated with IPD modality (intermittent peritoneal dialysis) * Malignant disease without remission * Patients with artificial joints, amputations, stents, or pacemaker * Patients with congestive heart failure or coronary artery disease NYHA (New York Heart Association) III and higher * Active HBV (hepatitis B virus)or HCV(hepatitis C virus)infection- HIV positive * Participation in an interventional clinical study during the preceding 30 days * Any condition which could interfere with the patient's ability to comply with the study
References
Publications (0)
Data not yet available
No reference posted for this study.