PDOne: Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD

• Sponsor: Fresenius Medical Care Deutschland GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00794326
• Collaborator: (none)
• Enrollment: 140
• Locations: 29
• Arms: 2
• Duration (Months): 74
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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 sodium/water balance.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Failure	Drug: Solution for Peritoneal Dialysis	Phase 3

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

• Study Type: Interventional
• Anticipated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PDsol 12 Treatment with a peritoneal dialysis solution containing a low concentration of sodium.	Drug: Solution for Peritoneal Dialysis; Treatment with one bag per day during 6 months
Active Comparator: Gambrosol trio 40 Treatment with the peritoneal dialysis solution Gambrosol trio 40 isotonic bag (1.5%)	Drug: Solution for Peritoneal Dialysis; Treatment with one bag per day during 6 months

Outcome Measures

Primary Outcome Measures

1. 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. [At the beginning and after 8 weeks of treatment]

Secondary Outcome Measures

1. Measurement of Residual Renal Function [At the beginning, at two and six months of treatment]

2. Follow-up of frequency of hyponatremia, of AE and SAE [During whole period of the study]

3. Assessment of changes in sodium removal [At the beginning and at two months of treatment]

4. Assessment of decrease in total body water (extra and intra cellular water)and of the body weigh changes [At the beginning, at two and at six months of treatment]

5. Measurement of 24hours peritoneal clearance [At the beginning and at 2 months of treatment]

6. Office systolic and diastolic blood pressure measurement at month 2 and 6 versus T0 [At the beginning, at two and six months of treatment]

7. Office systolic and diastolic blood pressure measurement during follow up period [End of treatment, follow-up period]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen		Denmark
2	CHU Saint-Jacques	Besançon		France	25000
3	CHRU	Caen		France	14033
4	Hospital of Chambéry	Chambery		France
5	CH Colmar	Colmar		France
6	Calydial Dialysis Center	Irigny		France
7	Bichat-Claude Bernard Hospital	Paris		France
8	ARPDD	Reims		France	51726
9	CHRU de Strasbourg	Strasbourg		France
10	KfH-Nierenzentrum am Krankenhaus Oststadt	Hannover		Germany	30659
11	University Hospital of Heidelberg	Heidelberg		Germany
12	KfH-Nierenzentrum	Köln		Germany	51109
13	Nephrology center Offenburg	Offenburg		Germany
14	KfH-Nierenzentrum	Passau		Germany	94032
15	PHV - Nephrologisches Zentrum Stuttgart	Stuttgart		Germany
16	KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder	Trier		Germany	54292
17	Södra Älvborgsläns Hospital	Borås		Sweden
18	University Hospital of Sahlgrenska	Göteborg		Sweden
19	University Hospital of Lund	Lund		Sweden
20	University Hospital of Malmö	Malmö		Sweden
21	Skarborgs Hospital	Skövde		Sweden
22	Karolinska University Hospital	Stockholm		Sweden	14186
23	Norra Älvsborgs Hospital	Trollhättan		Sweden
24	Birmingham Heartlands Hospital	Birmingham		United Kingdom	B9 5SS
25	Southmead Hospital	Bristol		United Kingdom	BS10 5NB
26	The Royal London Hospital	London		United Kingdom	E1 1BB
27	Royal Shrewsbury Hospital	Shrewsbury		United Kingdom	SY3 8XQ
28	University of North Staffordshire - Renal Medicine - Royal Infirmary	Stoke on Trent		United Kingdom	ST47LN
29	Wolverhampton New Cross Hospital	Wolverhampton		United Kingdom	WV10 0QP

Sponsors and Collaborators

• Fresenius Medical Care Deutschland GmbH

Investigators

• Study Chair: Simon Davies, Prof, University Hospital of North Staffordshire, Stoke-on-Trent, UK
• Study Chair: Bengt Rippe, Prof, Lund University
• Study Chair: Börje Haraldsson, Prof, Sahlgrenska University Hospital, Göteborg, Sweden
• Study Chair: François Vrtovsnik, Prof, Bichat -Claude Bernard Hospital, Paris, France
• Study Chair: Vedat Schwenger, Dr, Universitätsklinik University Hospital, Heidelberg, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fresenius Medical Care Deutschland GmbH
• ClinicalTrials.gov Identifier: NCT00794326
• Other Study ID Numbers: 1449; EudraCT 2007-005365-35
• First Posted: Nov 20, 2008
• Last Update Posted: Feb 27, 2015
• Last Verified: Sep 1, 2014

• Keywords provided by Fresenius Medical Care Deutschland GmbH: Chronic Kidney Failure; Peritoneal Dialysis; Low sodium solution; Hypertension; Total Body Water
• Additional relevant MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Dialysis Solutions

Study Results

No Results Posted as of Feb 27, 2015