Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

NCT ID: NCT03874117

Last Updated: 2025-09-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2025-05-31

Brief Summary

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The study will determine the efficacy of twice weekly hemodialysis in patients with residual kidney function.

Detailed Description

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Hemodialysis patients who have residual kidney function will undergo two 4-week study (twice weekly versus thrice weekly hemodialysis) using a cross-over design. Blood, urine, and dialysate samples will be collected at the end of each study period to determine adequacy of treatment and to assess uremic solute levels. Participants will complete quality of life questionnaires and cognitive paper tests.

Conditions

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Hemodialysis Kidney Failure, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis

Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks.

Group Type OTHER

Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis

Intervention Type OTHER

Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks.

Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis

Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks.

Group Type OTHER

Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis

Intervention Type OTHER

Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks.

Interventions

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Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis

Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks.

Intervention Type OTHER

Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis

Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients on hemodialysis who have residual kidney function with residual urea clearance (Kru) \>2.5 mL/min.
* been on hemodialysis for at least 3 months.
* adherence to regular dialysis treatments.

Exclusion Criteria

* inability to achieve adequate hemodialysis.
* planned revision of hemodialysis vascular access.
* hospitalized within the past 2 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role lead

Responsible Party

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Tammy Sirich

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tammy Sirich, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford/VA Palo Alto Health Care System

Locations

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VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status

Santa Clara Valley Medical Center

San Jose, California, United States

Site Status

Satellite HealthCare

San Jose, California, United States

Site Status

Countries

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United States

References

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Lee S, Pham NM, Montez-Rath ME, Bolanos CG, Bonde SS, Meyer TW, Sirich TL. Twice Weekly versus Thrice Weekly Hemodialysis-A Pilot Cross-Over Equivalence Trial. Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1159-1168. doi: 10.2215/CJN.0000000000000507. Epub 2024 Jun 26.

Reference Type DERIVED
PMID: 38922689 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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R01DK118426

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SIT0003AGG

Identifier Type: -

Identifier Source: org_study_id

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