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

Primary Purpose

End Stage Renal Failure on Dialysis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hemodialysis
Patiromer Oral Product
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Failure on Dialysis focused on measuring Hemodialysis, Kidney Disease, Kidney Function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wake Forest Baptist Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hemodialysis and Pharmacologic Therapy

Conventional Hemodialysis Regimen

Arm Description

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 regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis

Outcomes

Primary Outcome Measures

Patients' Adherence to Study Protocol
≥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

Secondary Outcome Measures

24-hour Urine Volume
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
Change in Residual Kidney Function - Urea Clearance
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.
Change in Residual Kidney Function - Creatinine Clearance
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.

Full Information

First Posted
November 9, 2018
Last Updated
June 7, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03740048
Brief Title
A Pilot Trial of Twice-weekly Versus Thrice-weekly Hemodialysis in Patients With Incident End-stage Kidney Disease
Acronym
TWOPLUS-HD
Official Title
A Randomized Pilot Study of Hemodialysis Initiation Comparing Twice-Weekly Hemodialysis Plus Dialysis-Sparing Therapy Versus Thrice-Weekly Hemodialysis (The TWOPLUS-HD Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
November 4, 2021 (Actual)
Study Completion Date
November 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Failure on Dialysis
Keywords
Hemodialysis, Kidney Disease, Kidney Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemodialysis and Pharmacologic Therapy
Arm Type
Experimental
Arm Description
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)
Arm Title
Conventional Hemodialysis Regimen
Arm Type
Active Comparator
Arm Description
Hemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis
Intervention Type
Other
Intervention Name(s)
Hemodialysis
Intervention Description
Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.
Intervention Type
Drug
Intervention Name(s)
Patiromer Oral Product
Intervention Description
Participants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer.
Primary Outcome Measure Information:
Title
Patients' Adherence to Study Protocol
Description
≥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
Time Frame
6 months, 12 months, 24 months
Secondary Outcome Measure Information:
Title
24-hour Urine Volume
Description
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
Time Frame
Baseline, 6 Weeks, 12 Weeks, 24 Weeks
Title
Change in Residual Kidney Function - Urea Clearance
Description
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.
Time Frame
Baseline, 6 Weeks, 12 Weeks, 24 Weeks
Title
Change in Residual Kidney Function - Creatinine Clearance
Description
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.
Time Frame
Baseline, 6 Weeks, 12 Weeks, 24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana Murea, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
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A Pilot Trial of Twice-weekly Versus Thrice-weekly Hemodialysis in Patients With Incident End-stage Kidney Disease

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