NCT01753154

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2011

Typical duration for phase_4

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

1.7 years

First QC Date

December 17, 2012

Last Update Submit

April 29, 2016

Conditions

Chronic Renal Failure

Keywords

Peritoneal DialysisBiocompatible dialysis solutionHydration statusResidual renal functionBody composition monitorBioimpedance spectroscopyCancer antigen 125

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Solution B (balance PD solution)

EXPERIMENTAL

Treatment 8 weeks with solution B (balance PD solution), next 8 weeks with solution A (conventional PD solution)

Drug: Solution B (balance PD solution)

Solution A (conventional PD solution)

ACTIVE COMPARATOR

Treatment 8 weeks with solution A (conventional PD solution), next 8 weeks with solution B (balance PD solution)

Drug: Solution A (conventional PD solution)

Interventions

Solution B (balance PD solution)DRUG

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

Also known as: Balance
Solution B (balance PD solution)
Solution A (conventional PD solution)DRUG

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)

Also known as: CAPD 2, CAPD 3, CAPD 4, CAPD 17, CAPD 18 and CAPD 19
Solution A (conventional PD solution)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • APD patient ≥ 18 years
  • Patient is trained on and being treated with the sleep•safe APD cycler
  • Informed consent signed and dated by study patient and investigator/authorised physician
  • Ability to understand the nature and requirements of the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Centrum Dializ Fresenius Nephrocare

Gdansk, Poland

Location

Uniwersytecki Szpital Kliniczny nr 1

Lodz, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

Lublin, Poland

Location

Complejo hospitalario universitario de Albacete

Albacete, Spain

Location

Fundación Hospital Alcorcón

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mariano Feriani, MD

    Ospedale Umberto Oo, 30174 Mestre, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2012

First Posted

December 20, 2012

Study Start

July 1, 2011

Primary Completion

March 1, 2013

Study Completion

December 1, 2013

Last Updated

May 2, 2016

Record last verified: 2016-04

Locations

ES(4)PL(3)