Chronic Kidney FailurePhase 3PDOneNCT00794326
Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD
A Phase 3 study testing Solution for Peritoneal Dialysis in people with Chronic Kidney Failure, run by Fresenius Medical Care Deutschland GmbH at 29 sites in 5 countries.
Trial summary
The aim of this study is to assess the superiority of the new low sodium peritoneal dialysis (PD) solution PDsol 12 in comparison with a conventional, already marketed solution, Gambrosol trio 40, in the treatment of the hypertensive peritoneal dialysis patients with aim to decrease hypertension and to improve the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Failure
- What is being tested?
- Solution for Peritoneal Dialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 29 sitesin 5 countries
- Study dates
- Oct 2008to Dec 2014
- Phase
- Phase 3
- 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
- Chronic renal failure
- Stable patients on PD treatment
- Treatment at the study site for at least three months
- Treated in a CAPD program with a minimum of 3 bag exchanges with 6 or 7 days per week including at least one with duration of 4-6 hours, and at least one low strength bag per day, or in an APD program with at least one daytime exchange with duration of 4-6 hours using one low strength bag
- Hypertensive patients with high blood pressure at inclusion visit (Office SBP ≥ 140 and/or DBP ≥ 90 mmHg) or hypertensive patients receiving anti hypertensive medication including diuretics, disregarded blood pressure values
- Patients aged 18 years or more
Show all 9Show fewer
- Written consent to participate in the study (informed consent)
- Able to use a three-compartment bag
- Life expectancy and expected technical survival ≥ 9 months
Who cannot join
- Low blood pressure (Office sitting SBP ≤ 120 mmHg and confirmed by ABPM < or = to 105 mean 24h SBP)
- Orthostatic hypotension defined as Systolic OBP with a drop of > 20mmHg and symptomatic after standing for at least 1 minute
- Natremia < 130 mmol/l, after two consecutive measurements
- Chronic arrhythmia
- Pregnancy or lactation
- Participation in other studies during the study period which may affect the outcome of the present study
Show all 10Show fewer
- Peritonitis within one month prior to the study start
- Exit site and /or tunnel infection
- Patients unable to tolerate 2 L bag exchanges
- Patients on non-compatible PD system
Trial locations and contacts
29 sites in 5 countries.
29 sites in 5 countries
France8 sites
CHU Saint-Jacques
Besançon, 25000
CHRU
Caen, 14033
Hospital of Chambéry
Chambéry
CH Colmar
Colmar
Calydial Dialysis Center
Irigny
Bichat-Claude Bernard Hospital
Paris
ARPDD
Reims, 51726
CHRU de Strasbourg
Strasbourg
Germany7 sites
KfH-Nierenzentrum
Cologne, 51109
KfH-Nierenzentrum am Krankenhaus Oststadt
Hanover, 30659
University Hospital of Heidelberg
Heidelberg
Nephrology center Offenburg
Offenburg
KfH-Nierenzentrum
Passau, 94032
PHV - Nephrologisches Zentrum Stuttgart
Stuttgart
KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder
Trier, 54292
Sweden7 sites
Södra Älvborgsläns Hospital
Borås
University Hospital of Sahlgrenska
Gothenburg
University Hospital of Lund
Lund
University Hospital of Malmö
Malmö
Skarborgs Hospital
Skövde
Karolinska University Hospital
Stockholm, 14186
Norra Älvsborgs Hospital
Trollhättan
United Kingdom6 sites
Birmingham Heartlands Hospital
Birmingham, B9 5SS
Southmead Hospital
Bristol, BS10 5NB
The Royal London Hospital
London, E1 1BB
Royal Shrewsbury Hospital
Shrewsbury, SY3 8XQ
University of North Staffordshire - Renal Medicine - Royal Infirmary
Stoke-on-Trent, ST47LN
Wolverhampton New Cross Hospital
Wolverhampton, WV10 0QP
About this study
Official title: Multicentric, Parallel, Controlled, Randomized, Single-blind Clinical Evaluation of New Low Sodium Peritoneal Dialysis Solution on Patients With Hypertension Treated With Continuous Ambulatory or Automated Peritoneal Dialysis
The aim of this study is to assess the superiority of the new low sodium peritoneal dialysis (PD) solution PDsol 12 in comparison with a conventional, already marketed solution, Gambrosol trio 40, in the treatment of the hypertensive peritoneal dialysis patients with aim to decrease hypertension and to improve the sodium/water balance.
Read the detailed description
Hypertension as well as sodium and water retention are common in end-stage renal disease patients on peritoneal dialysis and expose patients to left ventricular hypertrophy and increase cardiovascular mortality.
Moreover the poor control of dry weight and sodium/water balance results in increased morbidity. A previous low sodium study and computer simulations show that sodium removal can be improved with a low sodium fluid, which allows achieving a negative sodium balance without altering water balance.
The aim of this study is to assess whether treatment with one low sodium bag can substitute for one isotonic glucose bag every day in order to reduce the blood pressure and/or medication for hypertension, defined as the primary endpoint.
In order to evaluate the main criteria, blood pressure, a 24hours Ambulatory Blood Pressure Monitoring (ABPM) will be performed twice during the study, at Baseline and at 8 weeks of treatment, according to the EMEA guidance recommendations for anti-hypertensive treatments. In addition, the self measurement of blood pressure will be performed by patients at home during three consecutive days before each visit as well as in case of symptoms of hypotension.
The study is designed in three periods:
- Run-in period during 1 month: a reference product Gambrosol Trio 40, one bag/ day will be used by all patients. This period is dedicated to train the patient in using of study product, to stabilize the patient in the PD treatment and to randomize the patient, by performing the 24h ABPM.
- Efficacy \& Safety period during 6 months: each patient will be treated with one of two product : PDsol 12 (studied product) or Gambrosol Trio 40 (reference product) during 6 months. The aim of this period is to evaluate the efficacy and long-term tolerance of new PD fluid.
- Follow-up period during 2 months: without treatment. This period is dedicated to ensure the safety of the patients after the study product treatment was stopped and to obtain the information about the reversibility of product effect.
- Conditions
- Chronic Kidney Failure
- Being tested
- Solution for Peritoneal Dialysis
- Keywords
- Chronic Kidney Failure, Peritoneal Dialysis, Low sodium solution, Hypertension, Total Body Water
- Medical subject headings
- Kidney Failure, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solution for Peritoneal DialysisDrug
Treatment with one bag per day during 6 months
| Study group | Role | What they receive |
|---|---|---|
| PDsol 12 | Experimental | Treatment with a peritoneal dialysis solution containing a low concentration of sodium. Receives: Drug: Solution for Peritoneal Dialysis |
| Gambrosol trio 40 | Active comparator | Treatment with the peritoneal dialysis solution Gambrosol trio 40 isotonic bag (1.5%) Receives: Drug: Solution for Peritoneal Dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary criterion is the ambulatory 24 h mean systolic blood pressure measurement and drug doses management after 2 months of treatment compared to Baseline.
Measured: At the beginning and after 8 weeks of treatment
Secondary outcomes (7)
Measurement of Residual Renal Function
Measured: At the beginning, at two and six months of treatment
Follow-up of frequency of hyponatremia, of AE and SAE
Measured: During whole period of the study
Assessment of changes in sodium removal
Measured: At the beginning and at two months of treatment
Assessment of decrease in total body water (extra and intra cellular water)and of the body weigh changes
Measured: At the beginning, at two and at six months of treatment
Measurement of 24hours peritoneal clearance
Measured: At the beginning and at 2 months of treatment
Office systolic and diastolic blood pressure measurement at month 2 and 6 versus T0
Measured: At the beginning, at two and six months of treatment
Office systolic and diastolic blood pressure measurement during follow up period
Measured: End of treatment, follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simon Davies, Prof, Study chair, University Hospital of North Staffordshire, Stoke-on-Trent, UKBengt Rippe, Prof, Study chair, Lund UniversityBörje Haraldsson, Prof, Study chair, Sahlgrenska University Hospital, Göteborg, SwedenFrançois Vrtovsnik, Prof, Study chair, Bichat -Claude Bernard Hospital, Paris, FranceVedat Schwenger, Dr, Study chair, Universitätsklinik University Hospital, Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794326
- Sponsor's protocol ID
- 1449
- Other IDs
- EudraCT 2007-005365-35
- Acronym
- PDOne
- Status last verified
- Sep 2014
- First submitted
- 18 Nov 2008
- Last updated
- 27 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Parallel, Controlled, Randomized, Single-blind Clinical Evaluation of New Low Sodium Peritoneal Dialysis Solution on Patients With Hypertension Treated With Continuous Ambulatory or Automated Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT00794326
- Acronym / sponsor ID
- PDOne / 1449
- Conditions
- Chronic Kidney Failure
- Keywords
- Chronic Kidney Failure, Peritoneal Dialysis, Low sodium solution, Hypertension, Total Body Water
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Nov 2008 (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.
The aim of this study is to assess the superiority of the new low sodium peritoneal dialysis (PD) solution PDsol 12 in comparison with a conventional, already marketed solution, Gambrosol trio 40, in the treatment of the hypertensive peritoneal dialysis patients with aim to decrease hypertension and to improve the sodium/water balance.
Detailed description
Hypertension as well as sodium and water retention are common in end-stage renal disease patients on peritoneal dialysis and expose patients to left ventricular hypertrophy and increase cardiovascular mortality.
Moreover the poor control of dry weight and sodium/water balance results in increased morbidity. A previous low sodium study and computer simulations show that sodium removal can be improved with a low sodium fluid, which allows achieving a negative sodium balance without altering water balance.
The aim of this study is to assess whether treatment with one low sodium bag can substitute for one isotonic glucose bag every day in order to reduce the blood pressure and/or medication for hypertension, defined as the primary endpoint.
In order to evaluate the main criteria, blood pressure, a 24hours Ambulatory Blood Pressure Monitoring (ABPM) will be performed twice during the study, at Baseline and at 8 weeks of treatment, according to the EMEA guidance recommendations for anti-hypertensive treatments. In addition, the self measurement of blood pressure will be performed by patients at home during three consecutive days before each visit as well as in case of symptoms of hypotension.
The study is designed in three periods:
- Run-in period during 1 month: a reference product Gambrosol Trio 40, one bag/ day will be used by all patients. This period is dedicated to train the patient in using of study product, to stabilize the patient in the PD treatment and to randomize the patient, by performing the 24h ABPM.
- Efficacy \& Safety period during 6 months: each patient will be treated with one of two product : PDsol 12 (studied product) or Gambrosol Trio 40 (reference product) during 6 months. The aim of this period is to evaluate the efficacy and long-term tolerance of new PD fluid.
- Follow-up period during 2 months: without treatment. This period is dedicated to ensure the safety of the patients after the study product treatment was stopped and to obtain the information about the reversibility of product effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDsol 12 | Experimental | Drug: Solution for Peritoneal DialysisTreatment with a peritoneal dialysis solution containing a low concentration of sodium. |
| Gambrosol trio 40 | Active comparator | Drug: Solution for Peritoneal DialysisTreatment with the peritoneal dialysis solution Gambrosol trio 40 isotonic bag (1.5%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Chronic renal failure
- Stable patients on PD treatment
- Treatment at the study site for at least three months
- Treated in a CAPD program with a minimum of 3 bag exchanges with 6 or 7 days per week including at least one with duration of 4-6 hours, and at least one low strength bag per day, or in an APD program with at least one daytime exchange with duration of 4-6 hours using one low strength bag
- Hypertensive patients with high blood pressure at inclusion visit (Office SBP ≥ 140 and/or DBP ≥ 90 mmHg) or hypertensive patients receiving anti hypertensive medication including diuretics, disregarded blood pressure values
Key exclusion criteria (10 listed)
- Low blood pressure (Office sitting SBP ≤ 120 mmHg and confirmed by ABPM < or = to 105 mean 24h SBP)
- Orthostatic hypotension defined as Systolic OBP with a drop of > 20mmHg and symptomatic after standing for at least 1 minute
- Natremia < 130 mmol/l, after two consecutive measurements
- Chronic arrhythmia
- Pregnancy or lactation
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 for Peritoneal DialysisTreatment with one bag per day during 6 months | Drug | Gambrosol trio 40, PDsol 12 |
Primary outcome
The primary criterion is the ambulatory 24 h mean systolic blood pressure measurement and drug doses management after 2 months of treatment compared to Baseline.
Time frame: At the beginning and after 8 weeks of treatment
7 secondary outcomes
Measurement of Residual Renal Function
Time frame: At the beginning, at two and six months of treatment
Follow-up of frequency of hyponatremia, of AE and SAE
Time frame: During whole period of the study
Assessment of changes in sodium removal
Time frame: At the beginning and at two months of treatment
Assessment of decrease in total body water (extra and intra cellular water)and of the body weigh changes
Time frame: At the beginning, at two and at six months of treatment
Measurement of 24hours peritoneal clearance
Time frame: At the beginning and at 2 months of treatment
Office systolic and diastolic blood pressure measurement at month 2 and 6 versus T0
Time frame: At the beginning, at two and six months of treatment
Office systolic and diastolic blood pressure measurement during follow up period
Time frame: End of treatment, follow-up period
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 27 Feb 2015.
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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.
Simon Davies, Prof study chair
University Hospital of North Staffordshire, Stoke-on-Trent, UK
Bengt Rippe, Prof study chair
Lund University
Börje Haraldsson, Prof study chair
Sahlgrenska University Hospital, Göteborg, Sweden
29 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Solution for Peritoneal Dialysis in people with Chronic Kidney Failure, run by Fresenius Medical Care Deutschland GmbH at 29 sites in 5 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 9 inclusion and 10 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 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in France, Germany, Sweden, United Kingdom, Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary criterion is the ambulatory 24 h mean systolic blood pressure measurement and drug doses management after 2 months of treatment compared to Baseline. (time frame: At the beginning and after 8 weeks of treatment). 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 27 Feb 2015.