The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis

Chronic Renal Failure Clinical Trial

Official title:

The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753154
• Other study ID #: PD-NL-04-EU
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2012
• Last updated: April 29, 2016
• Start date: July 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2016
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosPoland: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic

Intervention

Drug:
• Solution B (balance PD solution)
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)
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)

Locations

Country	Name	City	State
Poland	Centrum Dializ Fresenius Nephrocare	Gdansk,
Poland	Uniwersytecki Szpital Kliniczny nr 1	Lódz
Poland	Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie	Lublin
Spain	Complejo hospitalario universitario de Albacete	Albacete
Spain	Fundación Hospital Alcorcón	Madrid
Spain	Hospital Universitario Puerta de Hierro	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH

Countries where clinical trial is conducted

Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 weeks	No