NCT04017572

Brief Summary

This clinical study is designed to evaluate the theoretical prediction of a lower glucose absorption in optimized automated peritoneal dialysis regimes. Patients will receive both a standard 6 x 2L 1.36% glucose regime or an optimized 7 x 2 L 2.27% glucose + 5 x 2 L 0.1% glucose regime in a crossover fashion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

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

June 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

1.3 years

First QC Date

July 4, 2019

Last Update Submit

February 10, 2021

Conditions

End Stage Kidney DiseaseChronic Kidney Disease Requiring Chronic Dialysis

Keywords

dialysisperitoneal dialysis

Outcome Measures

Primary Outcomes (1)

  • Glucose absorption

    Amount of glucose absorbed across the peritoneal membrane during the treatment

    Through study completion, up to 1 year

Secondary Outcomes (5)

  • Ultrafiltration

    Through study completion, up to 1 year

  • Creatinine clearance

    Through study completion, up to 1 year

  • Urea clearance

    Through study completion, up to 1 year

  • Sodium removal

    Through study completion, up to 1 year

  • Incidence of complications

    Up to 14 days post-intervention

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR

APD-treatment with a net volume of 12 L 1.36 % anhydrous glucose peritoneal dialysis solution during 540 minutes.

Procedure: Automated peritoneal dialysis (APD)

Optimized treatment

ACTIVE COMPARATOR

APD-treatment with a net volume of 14 L 2.27 % anhydrous glucose peritoneal dialysis solution during 280 minutes followed by a net volume of 10 L 0.1 % glucose dialysis fluid during 200 minutes.

Procedure: Automated peritoneal dialysis (APD)

Interventions

Automated peritoneal dialysis (APD)PROCEDURE

Automated peritoneal dialysis (APD) using the Baxter HomeChoice Pro Cycler.

Optimized treatmentStandard treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 18 and 75 years;
  • duration of PD (automated peritoneal dialysis (APD) or continuous ambulatory peritoneal dialysis (CAPD)) \>4 weeks

You may not qualify if:

  • severe heart failure (New York Heart Association Functional Classification; NYHA III or IV);
  • pregnancy;
  • catheter malfunction or
  • peritonitis within 3 months prior to the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Privado Centro Médico de Córdoba

Córdoba, 5016, Argentina

Location

Related Publications (2)

  • Oberg CM, Rippe B. Optimizing Automated Peritoneal Dialysis Using an Extended 3-Pore Model. Kidney Int Rep. 2017 Apr 27;2(5):943-951. doi: 10.1016/j.ekir.2017.04.010. eCollection 2017 Sep.

    PMID: 29270500BACKGROUND

  • Bergling K, de Arteaga J, Ledesma F, Oberg CM. Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): study protocol for a randomized controlled crossover trial. Pilot Feasibility Stud. 2020 Jun 10;6:81. doi: 10.1186/s40814-020-00620-2. eCollection 2020.

    PMID: 32528722DERIVED

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

  • Carl M Öberg, M.D., Ph.D.

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 12, 2019

Study Start

June 1, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

February 12, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)