Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD (PDOne)
26. februar 2015 opdateret af: Fresenius Medical Care Deutschland GmbH
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
140
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Copenhagen, Danmark
- Rigshospitalet
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Birmingham, Det Forenede Kongerige, B9 5SS
- Birmingham Heartlands Hospital
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Bristol, Det Forenede Kongerige, BS10 5NB
- Southmead Hospital
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London, Det Forenede Kongerige, E1 1BB
- The Royal London Hospital
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Shrewsbury, Det Forenede Kongerige, SY3 8XQ
- Royal Shrewsbury Hospital
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Stoke on Trent, Det Forenede Kongerige, ST47LN
- University of North Staffordshire - Renal Medicine - Royal Infirmary
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Wolverhampton, Det Forenede Kongerige, WV10 0QP
- Wolverhampton New Cross Hospital
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Besançon, Frankrig, 25000
- CHU Saint-Jacques
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Caen, Frankrig, 14033
- CHRU
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Chambery, Frankrig
- Hospital of Chambéry
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Colmar, Frankrig
- CH Colmar
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Irigny, Frankrig
- Calydial Dialysis Center
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Paris, Frankrig
- Bichat-Claude Bernard Hospital
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Reims, Frankrig, 51726
- ARPDD
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Strasbourg, Frankrig
- CHRU de Strasbourg
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Borås, Sverige
- Södra Älvborgsläns Hospital
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Göteborg, Sverige
- University Hospital of Sahlgrenska
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Lund, Sverige
- University Hospital of Lund
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Malmö, Sverige
- University Hospital of Malmö
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Skövde, Sverige
- Skarborgs Hospital
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Stockholm, Sverige, 14186
- Karolinska University Hospital
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Trollhättan, Sverige
- Norra Älvsborgs Hospital
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Hannover, Tyskland, 30659
- KfH-Nierenzentrum am Krankenhaus Oststadt
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Heidelberg, Tyskland
- university Hospital of Heidelberg
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Köln, Tyskland, 51109
- KfH-Nierenzentrum
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Offenburg, Tyskland
- Nephrology center Offenburg
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Passau, Tyskland, 94032
- KfH-Nierenzentrum
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Stuttgart, Tyskland
- PHV - Nephrologisches Zentrum Stuttgart
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Trier, Tyskland, 54292
- KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
- Written consent to participate in the study (informed consent)
- Able to use a three-compartment bag
- Life expectancy and expected technical survival ≥ 9 months
Exclusion Criteria:
- 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
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: PDsol 12
Treatment with a peritoneal dialysis solution containing a low concentration of sodium.
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Treatment with one bag per day during 6 months
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Aktiv komparator: Gambrosol trio 40
Treatment with the peritoneal dialysis solution Gambrosol trio 40 isotonic bag (1.5%)
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Treatment with one bag per day during 6 months
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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.
Tidsramme: At the beginning and after 8 weeks of treatment
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At the beginning and after 8 weeks of treatment
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Measurement of Residual Renal Function
Tidsramme: At the beginning, at two and six months of treatment
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At the beginning, at two and six months of treatment
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Follow-up of frequency of hyponatremia, of AE and SAE
Tidsramme: During whole period of the study
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During whole period of the study
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Assessment of changes in sodium removal
Tidsramme: At the beginning and at two months of treatment
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At the beginning and at two months of treatment
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Assessment of decrease in total body water (extra and intra cellular water)and of the body weigh changes
Tidsramme: At the beginning, at two and at six months of treatment
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At the beginning, at two and at six months of treatment
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Measurement of 24hours peritoneal clearance
Tidsramme: At the beginning and at 2 months of treatment
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At the beginning and at 2 months of treatment
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Office systolic and diastolic blood pressure measurement at month 2 and 6 versus T0
Tidsramme: At the beginning, at two and six months of treatment
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At the beginning, at two and six months of treatment
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Office systolic and diastolic blood pressure measurement during follow up period
Tidsramme: End of treatment, follow-up period
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End of treatment, follow-up period
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Simon Davies, Prof, University Hospital of North Staffordshire, Stoke-on-Trent, UK
- Studiestol: Bengt Rippe, Prof, Lund University
- Studiestol: Börje Haraldsson, Prof, Sahlgrenska University Hospital, Göteborg, Sweden
- Studiestol: François Vrtovsnik, Prof, Bichat -Claude Bernard Hospital, Paris, France
- Studiestol: Vedat Schwenger, Dr, Universitätsklinik University Hospital, Heidelberg, Germany
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2008
Primær færdiggørelse (Faktiske)
1. december 2014
Studieafslutning (Faktiske)
1. december 2014
Datoer for studieregistrering
Først indsendt
18. november 2008
Først indsendt, der opfyldte QC-kriterier
19. november 2008
Først opslået (Skøn)
20. november 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. februar 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. februar 2015
Sidst verificeret
1. september 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1449 (CSL Behring)
- EudraCT 2007-005365-35
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .