Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD (PDOne)
26 febbraio 2015 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Anticipato)
140
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Copenhagen, Danimarca
- Rigshospitalet
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Besançon, Francia, 25000
- CHU Saint-Jacques
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Caen, Francia, 14033
- CHRU
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Chambery, Francia
- Hospital of Chambéry
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Colmar, Francia
- CH Colmar
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Irigny, Francia
- Calydial Dialysis Center
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Paris, Francia
- Bichat-Claude Bernard Hospital
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Reims, Francia, 51726
- ARPDD
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Strasbourg, Francia
- CHRU de Strasbourg
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Hannover, Germania, 30659
- KfH-Nierenzentrum am Krankenhaus Oststadt
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Heidelberg, Germania
- University Hospital of Heidelberg
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Köln, Germania, 51109
- KfH-Nierenzentrum
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Offenburg, Germania
- Nephrology center Offenburg
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Passau, Germania, 94032
- KfH-Nierenzentrum
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Stuttgart, Germania
- PHV - Nephrologisches Zentrum Stuttgart
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Trier, Germania, 54292
- KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder
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Birmingham, Regno Unito, B9 5SS
- Birmingham Heartlands Hospital
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Bristol, Regno Unito, BS10 5NB
- Southmead Hospital
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London, Regno Unito, E1 1BB
- The Royal London Hospital
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Shrewsbury, Regno Unito, SY3 8XQ
- Royal Shrewsbury Hospital
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Stoke on Trent, Regno Unito, ST47LN
- University of North Staffordshire - Renal Medicine - Royal Infirmary
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Wolverhampton, Regno Unito, WV10 0QP
- Wolverhampton New Cross Hospital
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Borås, Svezia
- Södra Älvborgsläns Hospital
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Göteborg, Svezia
- University Hospital of Sahlgrenska
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Lund, Svezia
- University Hospital of Lund
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Malmö, Svezia
- University Hospital of Malmö
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Skövde, Svezia
- Skarborgs Hospital
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Stockholm, Svezia, 14186
- Karolinska University Hospital
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Trollhättan, Svezia
- Norra Älvsborgs Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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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.
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Measurement of Residual Renal Function
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: End of treatment, follow-up period
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End of treatment, follow-up period
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Cattedra di studio: Simon Davies, Prof, University Hospital of North Staffordshire, Stoke-on-Trent, UK
- Cattedra di studio: Bengt Rippe, Prof, Lund University
- Cattedra di studio: Börje Haraldsson, Prof, Sahlgrenska University Hospital, Göteborg, Sweden
- Cattedra di studio: François Vrtovsnik, Prof, Bichat -Claude Bernard Hospital, Paris, France
- Cattedra di studio: Vedat Schwenger, Dr, Universitätsklinik University Hospital, Heidelberg, Germany
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 ottobre 2008
Completamento primario (Effettivo)
1 dicembre 2014
Completamento dello studio (Effettivo)
1 dicembre 2014
Date di iscrizione allo studio
Primo inviato
18 novembre 2008
Primo inviato che soddisfa i criteri di controllo qualità
19 novembre 2008
Primo Inserito (Stima)
20 novembre 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
27 febbraio 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 febbraio 2015
Ultimo verificato
1 settembre 2014
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1449 (Altro identificatore: CSL Behring)
- EudraCT 2007-005365-35
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .