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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK118426 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The study will determine the efficacy of twice weekly hemodialysis in patients with residual kidney function.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis | Other | Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks. |
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| Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis | Other | Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis | Other | Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| QOL: Kidney Disease Quality of Life (KDQOL36) | Kidney Disease Quality of Life: Health-related quality of life, with higher scores being better. Minimum is 0, maximum is 100. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Solute Concentration | Plasma concentration of p-cresol sulfate | 4 weeks |
| Symptom | Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tammy Sirich, MD | Stanford/VA Palo Alto Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | United States | ||
| Santa Clara Valley Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38922689 | Derived | 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. |
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58 participants signed informed consent. 27 did not meet trial eligibility criteria during the run-in period and so were not randomized to the study periods. 31 participants were randomized to the study periods.
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| ID | Title | Description |
|---|---|---|
| FG000 | Twice Weekly Hemodialysis Then Thrice Weekly Hemodialysis | Participants will undergo hemodialysis twice per week for 4 weeks and then hemodialysis thrice per week for 4 weeks. |
| FG001 | Thrice Weekly Hemodialysis Then Twice Weekly Hemodialysis |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention (4 Weeks) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2025 | Jul 7, 2025 |
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| Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis | Other | Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks. |
|
| 4 weeks |
| Trail B Making Test | Cognitive test: The Trail B Making Test assesses working memory, cognitive flexibility, processing speed, and visual-motor tracking. There are numbers and letters on a page. The participant must connect the number to letter in order. For example, they would start at 1 and draw a line to A, then draw a line to 2, then draw a line to B, then draw a line to 3. The time is recorded in seconds. | 4 weeks |
| Digit Symbol Substitution Test | Cognitive test: Digit Symbol Substitution Test, measured in number correct | 4 weeks |
| San Jose |
| California |
| 95128 |
| United States |
| Satellite HealthCare | San Jose | California | 95128 | United States |
Participants will undergo hemodialysis thrice per week for 4 weeks and then hemodialysis twice per week for 4 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| Second Intervention (4 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Twice Weekly Hemodialysis Then Thrice Weekly Hemodialysis | Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks. |
| BG001 | Thrice Weekly Hemodialysis Then Twice Weekly Hemodialysis | Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Residual kidney urea clearance (Kru) | Mean | Standard Deviation | mL/min |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | QOL: Kidney Disease Quality of Life (KDQOL36) | Kidney Disease Quality of Life: Health-related quality of life, with higher scores being better. Minimum is 0, maximum is 100. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
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| Secondary | Solute Concentration | Plasma concentration of p-cresol sulfate | Posted | Mean | Inter-Quartile Range | mg/dl | 4 weeks |
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| Secondary | Symptom | Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
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| Secondary | Trail B Making Test | Cognitive test: The Trail B Making Test assesses working memory, cognitive flexibility, processing speed, and visual-motor tracking. There are numbers and letters on a page. The participant must connect the number to letter in order. For example, they would start at 1 and draw a line to A, then draw a line to 2, then draw a line to B, then draw a line to 3. The time is recorded in seconds. | Posted | Mean | Standard Deviation | seconds | 4 weeks |
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| Secondary | Digit Symbol Substitution Test | Cognitive test: Digit Symbol Substitution Test, measured in number correct | Posted | Mean | Standard Deviation | number correct | 4 weeks |
|
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4 weeks for each intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Twice Weekly Hemodialysis | This intervention is when participants were on the twice weekly hemodialysis period for 4 weeks. | 0 | 26 | 0 | 26 | 0 | 26 |
| EG001 | Thrice Weekly Hemodialysis | This intervention is when participants were on the thrice weekly hemodialysis period for 4 weeks. | 0 | 25 | 0 | 25 | 0 | 25 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tammy Sirich | VA Palo Alto | 6504935000 | tsirich@stanford.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2025 | Jul 7, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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