A Pilot Trial of Twice-weekly Versus Thrice-weekly Hemodialysis in Patients With Incident End-stage Kidney Disease (TWOPLUS-HD)

A Randomized Pilot Study of Hemodialysis Initiation Comparing Twice-Weekly Hemodialysis Plus Dialysis-Sparing Therapy Versus Thrice-Weekly Hemodialysis (The TWOPLUS-HD Trial)

The optimal frequency of hemodialysis treatments in patients with incident end-stage kidney disease in not known. This pilot trial will randomize patients with incident end-stage kidney disease due to chronic kidney disease progression to two different regimens of hemodialysis: i) twice-weekly hemodialysis for six weeks with adjuvant pharmacologic medications followed by thrice-weekly hemodialysis, or ii) thrice-weekly hemodialysis. The study will test feasibility of stepwise hemodialysis, and the effects of the two regimens of hemodialysis on residual kidney function.

Study Overview

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ≥18 years
  • Incident ESKD from CKD progression (including a failing renal transplant)
  • Are deemed to require dialysis initiation by the treating nephrologist
  • Have elected HD for renal replacement therapy (RRT)

Exclusion Criteria:

  • Have urine output <500ml per day
  • Have ESKD as a result of severe acute kidney injury (AKI) (stage 3 AKI defined by Acute Kidney Injury Network [AKIN]) criteria)
  • Abrupt decline in kidney function preceding HD therapy initiation (i.e., if eGFR was ≥30 mL/min/1.73 m2 3 months prior to the initiation of dialysis therapy)
  • Are scheduled to undergo transplantation from a live donor within the next 6 months
  • Have an active diagnosis of hepatorenal syndrome
  • Have a significant malignancy that is likely to impact survival
  • Have a medical condition that would jeopardize the safety of the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hemodialysis and Pharmacologic Therapy
Hemodialysis regimen at the initiation of dialysis treatment: Twice-weekly hemodialysis plus adjunctive pharmacologic therapy (loop diuretic, potassium-binding agent, and sodium bicarbonate) for six consecutive weeks, continued by thrice-weekly hemodialysis (intervention group)
Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.
Participants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer.
Active Comparator: Conventional Hemodialysis Regimen
Hemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis
Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' Adherence to Study Protocol
Time Frame: 6 months, 12 months, 24 months
≥95% of participants randomized in the intervention group will adhere to the HD regimen. All participants who completed 6 and 12 months of follow-up completed interdialytic timed urine collections - Patient adherence to the study protocol was assessed by the number of participants randomized to each intervention who adhered to the study protocol and at 6 months and at 12 months
6 months, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour Urine Volume
Time Frame: Baseline, 6 Weeks, 12 Weeks, 24 Weeks
Residual renal clearance was calculated based on 24-hour urine collection performed at baseline at enrollment; and interdialytic urine collection performed at baseline, 6 Weeks, 12 Weeks and 24 Weeks
Baseline, 6 Weeks, 12 Weeks, 24 Weeks
Change in Residual Kidney Function - Urea Clearance
Time Frame: Baseline, 6 Weeks, 12 Weeks, 24 Weeks
Residual renal clearance was calculated based on 24-hour urine collection performed at baseline at enrollment; and interdialytic urine collection performed during weeks 6, 12, and 24.
Baseline, 6 Weeks, 12 Weeks, 24 Weeks
Change in Residual Kidney Function - Creatinine Clearance
Time Frame: Baseline, 6 Weeks, 12 Weeks, 24 Weeks
Residual renal clearance was calculated based on 24-hour urine collection performed at baseline at enrollment; and interdialytic urine collection performed during weeks 6, 12, and 24.
Baseline, 6 Weeks, 12 Weeks, 24 Weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term change in residual kidney function
Time Frame: up to 24 months
Residual renal urea clearance (Krt/Vurea) will be calculated based on inter-dialytic urine collection at week 24 and week 48 of hemodialysis. The change in Krt/Vurea from baseline will be compared between the two treatment arms.
up to 24 months
Survival
Time Frame: up to 24 months
Exploratory analyses will compare the mortality rate between the two schedules of hemodialysis at week 12, week 24 and week 48 after dialysis initiation.
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mariana Murea, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2019

Primary Completion (Actual)

November 4, 2021

Study Completion (Actual)

November 4, 2021

Study Registration Dates

First Submitted

November 9, 2018

First Submitted That Met QC Criteria

November 9, 2018

First Posted (Actual)

November 14, 2018

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

April 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After study completion, de-identified participant data may be provided to other researchers in the filed if requested. The request(s) will be reviewed by the principal investigator and other study members to determine if appropriate.

IPD Sharing Time Frame

2-4 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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