Trial Outcomes & Findings for A Pilot Trial of Twice-weekly Versus Thrice-weekly Hemodialysis in Patients With Incident End-stage Kidney Disease (NCT NCT03740048)

Last Updated: 2023-06-09

Results Overview

≥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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

51 participants

Primary outcome timeframe

6 months, 12 months, 24 months

Results posted on

2023-06-09

Participant Flow

51 patients consented to participate and enrolled for the study. 48 patients were randomized to treatment with twice-weekly HD and adjuvant pharmacotherapy for 6 weeks followed by thrice-weekly HD (n = 23) or continued usual care treatment with thrice-weekly HD (n = 25).

77 patients (41%) were approached for study participation. Of those, 51 (66%) consented to participate, resulting in 48 patients randomized to treatment with twice-weekly HD and adjuvant pharmacotherapy for 6 weeks followed by thrice-weekly HD (n = 23) or continued usual care treatment with thrice-weekly HD (n = 25).

Participant milestones

Participant milestones
Measure	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: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms. Patiromer Oral Product: Participants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer.	Conventional Hemodialysis Regimen Hemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis Hemodialysis: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.
Overall Study STARTED	23	25
Overall Study COMPLETED	17	16
Overall Study NOT COMPLETED	6	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms. Patiromer Oral Product: Participants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer.	Conventional Hemodialysis Regimen Hemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis Hemodialysis: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.
Overall Study Withdrawal by Subject	1	1
Overall Study Death	1	6
Overall Study Switched to thrice-weekly HD	2	0
Overall Study Switched to Peritoneal Dialysis	2	0
Overall Study Lost to Follow-up	0	1
Overall Study Non-compliance with HD	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hemodialysis and Pharmacologic Therapy n=23 Participants 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: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms. Patiromer Oral Product: Participants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer.	Conventional Hemodialysis Regimen n=25 Participants Hemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis Hemodialysis: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.	Total n=48 Participants Total of all reporting groups
Age, Continuous	59.1 years STANDARD_DEVIATION 15.0 • n=5 Participants	63.3 years STANDARD_DEVIATION 12.8 • n=7 Participants	61.3 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Body mass index	32.5 kg/m^2 STANDARD_DEVIATION 9.4 • n=5 Participants	31.8 kg/m^2 STANDARD_DEVIATION 8.4 • n=7 Participants	32.1 kg/m^2 STANDARD_DEVIATION 8.8 • n=5 Participants
Body surface area	2.1 m^2 STANDARD_DEVIATION 0.2 • n=5 Participants	2.0 m^2 STANDARD_DEVIATION 0.3 • n=7 Participants	2.06 m^2 STANDARD_DEVIATION 0.3 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months, 12 months, 24 months

Population: Participants were censored at death, HD withdrawal, or conversion to peritoneal dialysis. Not included in data analysis were participants who withdrew consent, were withdrawn from the study because of nonadherence to HD treatments, or were lost to follow-up.

Outcome measures

Outcome measures
Measure	Hemodialysis and Pharmacologic Therapy n=23 Participants 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: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms. Patiromer Oral Product: Participants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer.	Conventional Hemodialysis Regimen n=25 Participants Hemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis Hemodialysis: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.
Patients' Adherence to Study Protocol Patients adherence to study protocol	22 Participants	24 Participants
Patients' Adherence to Study Protocol interdialytic timed urine collections at 6 month followup	19 Participants	19 Participants
Patients' Adherence to Study Protocol interdialytic timed urine collections at 12 month followup	10 Participants	10 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Hemodialysis and Pharmacologic Therapy n=23 Participants 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: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms. Patiromer Oral Product: Participants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer.	Conventional Hemodialysis Regimen n=25 Participants Hemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis Hemodialysis: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.
24-hour Urine Volume Urine volume at Baseline	914 mL/day Interval 654.0 to 1174.0	1424 mL/day Interval 976.0 to 1872.0
24-hour Urine Volume Urine volume at Week 6	504 mL/day Interval 335.0 to 673.0	553 mL/day Interval 384.0 to 723.0
24-hour Urine Volume Urine volume at 12 weeks	479 mL/day Interval 288.0 to 670.0	484 mL/day Interval 292.0 to 676.0
24-hour Urine Volume Urine volume at 24 Weeks	862 mL/day Interval 624.0 to 1099.0	876 mL/day Interval 638.0 to 1114.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Hemodialysis and Pharmacologic Therapy n=23 Participants 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: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms. Patiromer Oral Product: Participants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer.	Conventional Hemodialysis Regimen n=25 Participants Hemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis Hemodialysis: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.
Change in Residual Kidney Function - Urea Clearance Baseline Renal Urea Clearance	3.3 mL/min/1.73m^2 Interval 2.0 to 4.5	4.1 mL/min/1.73m^2 Interval 2.9 to 5.3
Change in Residual Kidney Function - Urea Clearance Week 6 Renal Urea Clearance	2.3 mL/min/1.73m^2 Interval 1.6 to 2.9	2.3 mL/min/1.73m^2 Interval 1.6 to 3.0
Change in Residual Kidney Function - Urea Clearance Week 12 Renal Urea Clearance	2.1 mL/min/1.73m^2 Interval 1.4 to 2.8	2.0 mL/min/1.73m^2 Interval 1.4 to 2.7
Change in Residual Kidney Function - Urea Clearance Week 24 Renal Urea Clearance	1.6 mL/min/1.73m^2 Interval 0.9 to 2.2	2.2 mL/min/1.73m^2 Interval 1.6 to 2.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Hemodialysis and Pharmacologic Therapy n=23 Participants 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: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms. Patiromer Oral Product: Participants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer.	Conventional Hemodialysis Regimen n=25 Participants Hemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis Hemodialysis: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.
Change in Residual Kidney Function - Creatinine Clearance Baseline Renal Creatinine Clearance	8.4 mL/min/1.73m^2 Interval 5.6 to 11.3	10.8 mL/min/1.73m^2 Interval 8.1 to 13.5
Change in Residual Kidney Function - Creatinine Clearance Week 6 Renal Creatinine Clearance	5.5 mL/min/1.73m^2 Interval 2.9 to 8.1	6.8 mL/min/1.73m^2 Interval 4.7 to 9.0
Change in Residual Kidney Function - Creatinine Clearance Week 12 Renal Creatinine Clearance	5.3 mL/min/1.73m^2 Interval 3.2 to 7.4	5.8 mL/min/1.73m^2 Interval 4.1 to 7.5
Change in Residual Kidney Function - Creatinine Clearance Week 24 Renal Creatinine Clearance	5.6 mL/min/1.73m^2 Interval 3.9 to 7.3	5.4 mL/min/1.73m^2 Interval 3.7 to 7.2

Adverse Events

Hemodialysis and Pharmacologic Therapy

Serious events: 11 serious events

Other events: 0 other events

Deaths: 1 deaths

Conventional Hemodialysis Regimen

Serious events: 12 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Hemodialysis and Pharmacologic Therapy n=22 participants at risk 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: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms. Patiromer Oral Product: Participants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer.	Conventional Hemodialysis Regimen n=22 participants at risk Hemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis Hemodialysis: Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.
Cardiac disorders hospitalization	4.5% 1/22 • Monthly basis up to Year 2 Three patients from the conventional group were excluded from the analysis due to insufficient data resulting from early consent withdrawal, non-compliance with HD due to no-show, and loss to follow-up. In addition, one patient from the incremental group was also not included in the analysis due to consent withdrawal.	18.2% 4/22 • Monthly basis up to Year 2 Three patients from the conventional group were excluded from the analysis due to insufficient data resulting from early consent withdrawal, non-compliance with HD due to no-show, and loss to follow-up. In addition, one patient from the incremental group was also not included in the analysis due to consent withdrawal.
Vascular disorders Hospitalization	18.2% 4/22 • Monthly basis up to Year 2 Three patients from the conventional group were excluded from the analysis due to insufficient data resulting from early consent withdrawal, non-compliance with HD due to no-show, and loss to follow-up. In addition, one patient from the incremental group was also not included in the analysis due to consent withdrawal.	4.5% 1/22 • Monthly basis up to Year 2 Three patients from the conventional group were excluded from the analysis due to insufficient data resulting from early consent withdrawal, non-compliance with HD due to no-show, and loss to follow-up. In addition, one patient from the incremental group was also not included in the analysis due to consent withdrawal.
General disorders hospitalization	27.3% 6/22 • Monthly basis up to Year 2 Three patients from the conventional group were excluded from the analysis due to insufficient data resulting from early consent withdrawal, non-compliance with HD due to no-show, and loss to follow-up. In addition, one patient from the incremental group was also not included in the analysis due to consent withdrawal.	31.8% 7/22 • Monthly basis up to Year 2 Three patients from the conventional group were excluded from the analysis due to insufficient data resulting from early consent withdrawal, non-compliance with HD due to no-show, and loss to follow-up. In addition, one patient from the incremental group was also not included in the analysis due to consent withdrawal.
Nervous system disorders hospitalization	0.00% 0/22 • Monthly basis up to Year 2 Three patients from the conventional group were excluded from the analysis due to insufficient data resulting from early consent withdrawal, non-compliance with HD due to no-show, and loss to follow-up. In addition, one patient from the incremental group was also not included in the analysis due to consent withdrawal.	22.7% 5/22 • Monthly basis up to Year 2 Three patients from the conventional group were excluded from the analysis due to insufficient data resulting from early consent withdrawal, non-compliance with HD due to no-show, and loss to follow-up. In addition, one patient from the incremental group was also not included in the analysis due to consent withdrawal.
Infections and infestations hospitalization	18.2% 4/22 • Monthly basis up to Year 2 Three patients from the conventional group were excluded from the analysis due to insufficient data resulting from early consent withdrawal, non-compliance with HD due to no-show, and loss to follow-up. In addition, one patient from the incremental group was also not included in the analysis due to consent withdrawal.	40.9% 9/22 • Monthly basis up to Year 2 Three patients from the conventional group were excluded from the analysis due to insufficient data resulting from early consent withdrawal, non-compliance with HD due to no-show, and loss to follow-up. In addition, one patient from the incremental group was also not included in the analysis due to consent withdrawal.

Other adverse events

Adverse event data not reported

Additional Information

Dr Zhidong Lin

Wake Health

Phone: 3367138720

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place