| Trial ID: | L0106 |
| Source ID: | NCT01753154
|
| Associated Drug: |
Solution B (Balance Pd Solution)
|
| Title: |
The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Renal Failure
|
| Interventions: |
DRUG: Solution B (balance PD solution)|DRUG: Solution A (conventional PD solution)
|
| Outcome Measures: |
Primary: CA 125 (cancer antigen 125) appearance rate in the 24 hours effluent and estimated hydration, The appearance rate is defined as the sum of the amount of CA125 determined in each outflow bag (concentration of CA125 in outflow multiplied with outflow volume) divided by the real cumulative dwell time of all dwells performed on the day of the 24-hour dialysate collection., 16 weeks |
|
| Sponsor/Collaborators: |
Sponsor: Fresenius Medical Care Deutschland GmbH
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
25
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-07
|
| Completion Date: |
2013-12
|
| Results First Posted: |
|
| Last Update Posted: |
2016-05-02
|
| Locations: |
Centrum Dializ Fresenius Nephrocare, Gdańsk,, Poland|Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Lublin, Poland|Uniwersytecki Szpital Kliniczny nr 1, Łódź, Poland|Complejo hospitalario universitario de Albacete, Albacete, Spain|Fundación Hospital Alcorcón, Madrid, Spain|Hospital Universitario Puerta de Hierro, Madrid, Spain|Hospital Universitario Ramón y Cajal, Madrid, Spain
|
| URL: |
https://clinicaltrials.gov/show/NCT01753154
|
