Chronic Renal FailurePhase 4NCT01753154
The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis
A Phase 4 study testing Solution B (balance PD solution) and Solution A (conventional PD solution) in people with Chronic Renal Failure, run by Fresenius Medical Care Deutschland GmbH at 7 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Solution B (balance PD solution) and Solution A (conventional PD solution)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jul 2011to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Spain4 sites
Complejo hospitalario universitario de Albacete
Albacete
Fundación Hospital Alcorcón
Madrid
Hospital Universitario Puerta de Hierro
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Poland3 sites
Centrum Dializ Fresenius Nephrocare
Gdansk
Uniwersytecki Szpital Kliniczny nr 1
Lodz
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin
About this study
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.
Read the detailed description
Equivalence of the investigational PD solution balance regarding fluid status compared to the conventional PD solution.
Effects of balance on inflammation and systemic advanced glycation end products formation.
Effects of balance on peritoneal and total urea clearance, on peritoneal and total creatinine clearance and on ultrafiltration, on residual diuresis and on cholesterol levels.
Safety of the investigational PD solution balance and the conventional PD solution as a control drug.
The mesothelial cell mass assessed by Cancer Antigen 125 is affected by the use of the type of PD solution in APD patients using sleep•safe. Treating patients with the PD solution balance leads to not more than 1 litre difference in hydration in comparison to the conventional PD solution which is considered as clinically not relevant regarding blood pressure.
- Conditions
- Chronic Renal Failure
- Being tested
- Solution B (balance PD solution), Solution A (conventional PD solution)
- Keywords
- Peritoneal Dialysis, Biocompatible dialysis solution, Hydration status, Residual renal function, Body composition monitor, Bioimpedance spectroscopy, Cancer antigen 125
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solution B (balance PD solution)Drug
Also called Balance
balance 1.5% glucose, solution for peritoneal dialysis; balance 2.3% glucose, solution for peritoneal dialysis; balance 4.25% glucose, solution for peritoneal dialysis, each with 1.25 mmol/l or 1.75 mmol/l calcium
Solution A (conventional PD solution)Drug
Also called CAPD 2, CAPD 3, CAPD 4, CAPD 17, CAPD 18 and CAPD 19
Solutions for peritoneal dialysis: CAPD 2 (1.5% glucose, 1.75mmmol/l calcium), CAPD 3 (4.25 % glucose, 1.75mmmol/l calcium), CAPD 4 (2.3% glucose, 1.75mmmol/l calcium), CAPD 17 (1.5% glucose, 1.25mmmol/l calcium), CAPD 18 (4.25% glucose, 1.25mmmol/l calcium) and CAPD 19 (2.3% glucose, 1.25mmmol/l calcium)
| Study group | Role | What they receive |
|---|---|---|
| Solution B (balance PD solution) | Experimental | Treatment 8 weeks with solution B (balance PD solution), next 8 weeks with solution A (conventional PD solution) Receives: Drug: Solution B (balance PD solution) |
| Solution A (conventional PD solution) | Active comparator | Treatment 8 weeks with solution A (conventional PD solution), next 8 weeks with solution B (balance PD solution) Receives: Drug: Solution A (conventional PD solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJul 2011
- Primary completionMar 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mariano Feriani, MD, Principal investigator, Ospedale Umberto Oo, 30174 Mestre, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753154
- Sponsor's protocol ID
- PD-NL-04-EU
- Status last verified
- Apr 2016
- First submitted
- 17 Dec 2012
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT01753154
- Acronym / sponsor ID
- PD-NL-04-EU
- Conditions
- Chronic Renal Failure
- Keywords
- Peritoneal Dialysis, Biocompatible dialysis solution, Hydration status, Residual renal function, Body composition monitor, Bioimpedance spectroscopy, Cancer antigen 125
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Equivalence of the investigational PD solution balance regarding fluid status compared to the conventional PD solution.
Effects of balance on inflammation and systemic advanced glycation end products formation.
Effects of balance on peritoneal and total urea clearance, on peritoneal and total creatinine clearance and on ultrafiltration, on residual diuresis and on cholesterol levels.
Safety of the investigational PD solution balance and the conventional PD solution as a control drug.
The mesothelial cell mass assessed by Cancer Antigen 125 is affected by the use of the type of PD solution in APD patients using sleep•safe. Treating patients with the PD solution balance leads to not more than 1 litre difference in hydration in comparison to the conventional PD solution which is considered as clinically not relevant regarding blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solution B (balance PD solution) | Experimental | Drug: Solution B (balance PD solution)Treatment 8 weeks with solution B (balance PD solution), next 8 weeks with solution A (conventional PD solution) |
| Solution A (conventional PD solution) | Active comparator | Drug: Solution A (conventional PD solution)Treatment 8 weeks with solution A (conventional PD solution), next 8 weeks with solution B (balance PD solution) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solution B (balance PD solution)Also: Balancebalance 1.5% glucose, solution for peritoneal dialysis; balance 2.3% glucose, solution for peritoneal dialysis; balance 4.25% glucose, solution for peritoneal dialysis, each with 1.25 mmol/l or 1.75 mmol/l calcium | Drug | Solution B (balance PD solution) |
| Solution A (conventional PD solution)Also: CAPD 2, CAPD 3, CAPD 4, CAPD 17, CAPD 18 and CAPD 19Solutions for peritoneal dialysis: CAPD 2 (1.5% glucose, 1.75mmmol/l calcium), CAPD 3 (4.25 % glucose, 1.75mmmol/l calcium), CAPD 4 (2.3% glucose, 1.75mmmol/l calcium), CAPD 17 (1.5% glucose, 1.25mmmol/l calcium), CAPD 18 (4.25% glucose, 1.25mmmol/l calcium) and CAPD 19 (2.3% glucose, 1.25mmmol/l calcium) | Drug | Solution A (conventional PD solution) |
Primary outcome
CA 125 (cancer antigen 125) appearance rate in the 24 hours effluent and estimated hydration
Time frame: 16 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariano Feriani, MD principal investigator
Ospedale Umberto Oo, 30174 Mestre, Italy
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Solution B (balance PD solution) and Solution A (conventional PD solution) in people with Chronic Renal Failure, run by Fresenius Medical Care Deutschland GmbH at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CA 125 (cancer antigen 125) appearance rate in the 24 hours effluent and estimated hydration (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.