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| ID | Type | Description | Link |
|---|---|---|---|
| CER-2022C1-26300 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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This study is to prospectively compare clinical effectiveness between clinically- matched incremental hemodialysis and conventional hemodialysis in patients with incident kidney dysfunction requiring dialysis and residual kidney function.
The study will enroll 350 patients on chronic hemodialysis and 140 caregivers of enrolled patients. Patients will be randomized in 1:1 ratio to either incremental start hemodialysis or conventional hemodialysis. Caregivers will be followed along with patients for an average period of 2 years post randomization.
This study will analyze the effects of differentiated care with individualized hemodialysis on patient health related quality of life, fatigue, employment, and caregiver burden in patients with Kidney dysfunction requiring dialysis (KDRD) and appreciable kidney function.
This study will compare the outcomes in survival, hospitalization, preservation of the kidney function and quality of life between hemodialysis tailored to each patient needs (incremental) and conventional hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinically-matched Incremental Hemodialysis ( CMIHD) | Experimental | Randomized group to have hemodialysis prescription tailored based on residual kidney function and clinical manifestations starting at twice weekly. |
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| Conventional Hemodialysis (CHD) | Active Comparator | Randomized group to conventional three times a week hemodialysis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemodialysis twice weekly | Device | Frequency and duration of hemodialysis is tailored to the patient. Adjuvant pharmacotherapy is prescribed to maintain volume, electrolyte and acid-base homeostasis ( e.g., diuretics, sodium bicarbonate and potassium binding patiromer) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Clinical events of safety | composite of all-cause Emergency Department visits, hospitalizations, or death | year 2 |
| Measure | Description | Time Frame |
|---|---|---|
| EuroQOL-5D-5L scores Health-related quality of life Health-related quality of life and residual kidney function | Compare the effects of CMIHD and CHD - The descriptive system covers 5 dimensions of health (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with 5 levels of severity in each dimension (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems - Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize implementation processes using mixed methods - Intervention characteristics | Process evaluation will include a) Intervention characteristics, to assess organizational readiness to change, intervention acceptability and appropriateness; b) Inner setting characteristics, to assess barriers and facilitators to the adoption of HD intervention at the partnering organizations; c) External factors that mediate implementation; d) Adoption; e) Reach; f) Fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and g) Sustainability, to assess barriers and facilitators to maintaining intervention |
Patient eligibility Criteria:
Inclusion Criteria:
Residual Kidney Function Inclusion Criteria:
Exclusion Criteria:
Caregiver Eligibility Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brenda Burciu | Contact | 336-716-8671 | Brindusa.Burciu@advocatehealth.org | |
| Ben Bagwell | Contact | Benjamin.Bagwell@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Mariana Murea, MD | Wake Forest Health Sciences | Principal Investigator |
| Peter Kotanko | Renal Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Jacksonville | Florida | 32209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41366335 | Derived | Gautam SC, Awad AS, Niyyar VD, Flythe JE, Abdel-Rahman EM, Raimann JG, Woldemichael JA, Sheikh HI, Gaurav R, Kotanko P, Yang X, Gencerliler N, Divers J, Murea M. Patient monitoring in a pragmatic, multicenter trial of incremental hemodialysis: early experience from the TwoPlus randomized controlled trial. BMC Nephrol. 2025 Dec 9;27(1):39. doi: 10.1186/s12882-025-04659-2. | |
| 41314824 |
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Available upon investigator request
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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This study is a randomized parallel-group type 1 hybrid study
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| Hemodialysis thrice weekly | Other | Conventional hemodialysis regimen |
|
| year 2 |
| Trail Making Test B scores Health-related quality of life Health-related quality of life and residual kidney function | Patient participants' cognitive function will be assessed using change in Trail Making Test B score - The Trail Making Test measures your visual attention, mental flexibility, processing speed, and motor speed based on how quickly and accurately you connect dots in ascending order (either numerically or with alternating numbers and letters). The test can be used to diagnose dementia and other cognitive disorders - Higher scores indicate a higher degree of cognitive impairment | Baseline and months 6, 12, 18, & 24 |
| Standardized Outcomes in Nephrology (SONG) scores Health-related quality of life Health-related quality of life and residual kidney function | SONG-HD Fatigue score - The SONG-HD Fatigue measure consists of three items that assess (1) the effect of fatigue on life participation, (2) tiredness, and (3) level of energy. These dimensions are assessed on a four-point Likert scale indicating increasing severity, ranging from zero (not at all) to three (severely). Higher scores meaning higher severity | Baseline and months 6, 12, 18, & 24 |
| Time to recover from hemodialysis (HD) Health-related quality of life Health-related quality of life and residual kidney function | Patient-reported functional status and fatigue will be assessed using Time to recover from HD | Baseline and monthly up to 2 years |
| Caregiver burden Zarit Caregiver Burden Scores Health-related quality of life Health-related quality of life and residual kidney function | Caregiver burden will be assessed using the Zarit Caregiver Burden Scale - The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. 9. Higher scores indicate greater burden. A score of 17 or more was considered high burden. | Baseline, months 6, 12, 18, & 24 |
| Change in urine output | Urine collections will be analyzed at the lab used by the dialysis center | Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, and Year 2 |
| Change in kidney urea clearance (mL/min/1.73 m2) | Urine collections will be analyzed at the lab used by the dialysis center | Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, and Year 2 |
| Change in kidney creatinine clearance (mL/min/1.73 m2) | Urine collections will be analyzed at the lab used by the dialysis center | Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, and Year 2 |
| Hospital free days per 100 patient-days | The duration of hospital-free days will be determined for each patient and calculated in the whole cohort per 100 patient-days. It is anticipated an array of hospitalization events for each participant, ranging from no hospitalization to frequent hospitalizations per study period. All periods of hospitalization, per each participant, will be analyzed. A period of hospitalization will be computed from date of hospital admission to the date of discharge. Hospital-free days may include one or more discrete time segments of non-hospitalization between periods hospitalization. The total hospital-free days per patient participant will be calculated as total study days - hospitalization days. Hospital-free days will be normalized per 100 patient-days. | year 2 |
| Illness Intrusiveness Rating Scale | Patients will rate the degree of interference caused by HD treatments on the following domains: health, diet, work, active and passive recreation, financial situation, relationship with spouse, sex life, family and other social relations, self-expression/self- improvement, religious expression, and community/civic involvement. Individual item ratings and the sum across ratings will be recorded. The total scale has a range of 13 (minimum intrusiveness) to 91 (extreme intrusiveness). | Assessed at baseline and monthly up to 2 years |
| Employment status | The employment status for patients and caregivers will be assessed through surveys. | Baseline and months 6, 12, 18 and 24 |
| 2 years |
| Characterize implementation processes using mixed methods - Inner setting characteristics, to assess barriers and facilitators to the adoption of HD intervention at the partnering organizations | Process evaluation will include a) Intervention characteristics, to assess organizational readiness to change, intervention acceptability and appropriateness; b) Inner setting characteristics, to assess barriers and facilitators to the adoption of HD intervention at the partnering organizations; c) External factors that mediate implementation; d) Adoption; e) Reach; f) Fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and g) Sustainability, to assess barriers and facilitators to maintaining intervention | 2 years |
| Characterize implementation processes using mixed methods - External factors that mediate implementation | Process evaluation will include a) Intervention characteristics, to assess organizational readiness to change, intervention acceptability and appropriateness; b) Inner setting characteristics, to assess barriers and facilitators to the adoption of HD intervention at the partnering organizations; c) External factors that mediate implementation; d) Adoption; e) Reach; f) Fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and g) Sustainability, to assess barriers and facilitators to maintaining intervention | 2 years |
| Characterize implementation processes using mixed methods - Adoption | Process evaluation will include a) Intervention characteristics, to assess organizational readiness to change, intervention acceptability and appropriateness; b) Inner setting characteristics, to assess barriers and facilitators to the adoption of HD intervention at the partnering organizations; c) External factors that mediate implementation; d) Adoption; e) Reach; f) Fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and g) Sustainability, to assess barriers and facilitators to maintaining intervention | 2 years |
| Characterize implementation processes using mixed methods - Reach | Process evaluation will include a) Intervention characteristics, to assess organizational readiness to change, intervention acceptability and appropriateness; b) Inner setting characteristics, to assess barriers and facilitators to the adoption of HD intervention at the partnering organizations; c) External factors that mediate implementation; d) Adoption; e) Reach; f) Fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and g) Sustainability, to assess barriers and facilitators to maintaining intervention | 2 years |
| Characterize implementation processes using mixed methods - Fidelity, to assess adherence to serial timed urine collection and HD treatment schedule | Process evaluation will include a) Intervention characteristics, to assess organizational readiness to change, intervention acceptability and appropriateness; b) Inner setting characteristics, to assess barriers and facilitators to the adoption of HD intervention at the partnering organizations; c) External factors that mediate implementation; d) Adoption; e) Reach; f) Fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and g) Sustainability, to assess barriers and facilitators to maintaining intervention | 2 years |
| Characterize implementation processes using mixed methods - Sustainability, to assess barriers and facilitators to maintaining intervention | Process evaluation will include a) Intervention characteristics, to assess organizational readiness to change, intervention acceptability and appropriateness; b) Inner setting characteristics, to assess barriers and facilitators to the adoption of HD intervention at the partnering organizations; c) External factors that mediate implementation; d) Adoption; e) Reach; f) Fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and g) Sustainability, to assess barriers and facilitators to maintaining intervention | 2 years |
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Johns Hopkins University School of Medicine (JHUSM) | Recruiting | Baltimore | Maryland | 21218 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| University of Mississippi Medical Center | Recruiting | Jackson | Mississippi | 39216 | United States |
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| Renal Research Institute (RRI) | Recruiting | New York | New York | 10065 | United States |
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| Northwell Health | Recruiting | Queens | New York | 11427 | United States |
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| University of North Carolina Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
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| Atrium Health Wake Forest Baptist | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| University of Virginia (UVA) | Recruiting | Charlottesville | Virginia | 22904 | United States |
|
| Derived |
| Murea M, Foley KL, Gautam SC, Flythe JE, Raimann JG, Abdel-Rahman E, Awad AS, Niyyar VD, Kovach C, Roberts GV, Jefferson NM, Conway PT, Rosales LM, Woldemichael J, Sheikh HI, Raman G, Huml AM, Knicely DH, Hasan I, Makadia B, Lea J, Daugirdas JT, Gencerliler N, Divers J, Kotanko P; TwoPlus Research Consortium; Nwaozuru UC. Protocol for the process evaluation of a randomised clinical trial of incremental-start versus conventional haemodialysis: the TwoPlus study. BMJ Open. 2025 Nov 28;15(11):e094392. doi: 10.1136/bmjopen-2024-094392. |
| 38943204 | Derived | Murea M, Raimann JG, Divers J, Maute H, Kovach C, Abdel-Rahman EM, Awad AS, Flythe JE, Gautam SC, Niyyar VD, Roberts GV, Jefferson NM, Shahidul I, Nwaozuru U, Foley KL, Trembath EJ, Rosales ML, Fletcher AJ, Hiba SI, Huml A, Knicely DH, Hasan I, Makadia B, Gaurav R, Lea J, Conway PT, Daugirdas JT, Kotanko P; Two Plus Research Consortium. Comparative effectiveness of an individualized model of hemodialysis vs conventional hemodialysis: a study protocol for a multicenter randomized controlled trial (the TwoPlus trial). Trials. 2024 Jun 28;25(1):424. doi: 10.1186/s13063-024-08281-9. |
| 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 |