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Trial Outcomes & Findings for Theranova Randomized, Controlled, Trial (RCT) in China (NCT NCT05309291)

NCT ID: NCT05309291

Last Updated: 2025-07-14

Results Overview

One mid-week treatment day dialysis session, pre-dialysis and post-dialysis. The RR was calculated using the following formula: \[(Cpre-Cpost)/Cpre\], where Cpre and Cpost were the arterial plasma concentrations of λ FLC measured pre- and post- the mid-week dialysis session, respectively

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

323 participants

Primary outcome timeframe

Assessed at the mid-week treatment day dialysis session

Results posted on

2025-07-14

Participant Flow

Patients were recruited across 11 investigational sites in China, between June 2022 and July 2023.

Of the 323 patients enrolled, 274 patients met the study entry criteria and were randomized for treatment.

Participant milestones

Participant milestones
Measure
Theranova 400 Dialyzer
1 week, 1 mid-week HD therapy session. Theranova 400 Dialyzer: Dialysis performed in HD mode.
FX 800 Dialyzer
1 week, 1 mid-week HDF therapy session. FX 800 Dialyzer: Dialysis performed in HDF mode.
Overall Study
STARTED
138
136
Overall Study
As Treated
139
135
Overall Study
COMPLETED
138
135
Overall Study
NOT COMPLETED
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Theranova 400 Dialyzer
1 week, 1 mid-week HD therapy session. Theranova 400 Dialyzer: Dialysis performed in HD mode.
FX 800 Dialyzer
1 week, 1 mid-week HDF therapy session. FX 800 Dialyzer: Dialysis performed in HDF mode.
Overall Study
Adverse Event
0
1

Baseline Characteristics

Child-bearing potential outcome measure was assessed only in female participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Theranova 400 Dialyzer
n=138 Participants
1 week, 1 mid-week HD therapy session. Theranova 400 Dialyzer: Dialysis performed in HD mode.
FX 800 Dialyzer
n=136 Participants
1 week, 1 mid-week HDF therapy session. FX 800 Dialyzer: Dialysis performed in HDF mode.
Total
n=274 Participants
Total of all reporting groups
Age, Continuous
52.1 years
STANDARD_DEVIATION 11.99 • n=138 Participants
53.0 years
STANDARD_DEVIATION 11.43 • n=136 Participants
52.6 years
STANDARD_DEVIATION 11.70 • n=274 Participants
Sex: Female, Male
Female
44 Participants
n=138 Participants
35 Participants
n=136 Participants
79 Participants
n=274 Participants
Sex: Female, Male
Male
94 Participants
n=138 Participants
101 Participants
n=136 Participants
195 Participants
n=274 Participants
Race/Ethnicity, Customized
Ethnicity · Chinese
138 Participants
n=138 Participants
135 Participants
n=136 Participants
273 Participants
n=274 Participants
Race/Ethnicity, Customized
Ethnicity · Unknown
0 Participants
n=138 Participants
1 Participants
n=136 Participants
1 Participants
n=274 Participants
Child-bearing potential
Yes
15 Participants
n=44 Participants • Child-bearing potential outcome measure was assessed only in female participants
12 Participants
n=35 Participants • Child-bearing potential outcome measure was assessed only in female participants
27 Participants
n=79 Participants • Child-bearing potential outcome measure was assessed only in female participants
Child-bearing potential
No
29 Participants
n=44 Participants • Child-bearing potential outcome measure was assessed only in female participants
23 Participants
n=35 Participants • Child-bearing potential outcome measure was assessed only in female participants
52 Participants
n=79 Participants • Child-bearing potential outcome measure was assessed only in female participants
Dialysis Vintage
7.17 years
STANDARD_DEVIATION 4.86 • n=138 Participants
6.28 years
STANDARD_DEVIATION 4.45 • n=136 Participants
6.73 years
STANDARD_DEVIATION 4.67 • n=274 Participants
Weight
65.00 kg
STANDARD_DEVIATION 10.62 • n=138 Participants
66.39 kg
STANDARD_DEVIATION 11.15 • n=136 Participants
65.69 kg
STANDARD_DEVIATION 10.89 • n=274 Participants
Dry Weight
62.47 kg
STANDARD_DEVIATION 10.39 • n=138 Participants
63.97 kg
STANDARD_DEVIATION 10.97 • n=136 Participants
63.22 kg
STANDARD_DEVIATION 10.69 • n=274 Participants
Height
167.86 cm
STANDARD_DEVIATION 7.28 • n=138 Participants
168.92 cm
STANDARD_DEVIATION 7.58 • n=136 Participants
168.39 cm
STANDARD_DEVIATION 7.44 • n=274 Participants
BMI
23.02 kg/m^2
STANDARD_DEVIATION 3.17 • n=138 Participants
23.20 kg/m^2
STANDARD_DEVIATION 3.19 • n=136 Participants
23.11 kg/m^2
STANDARD_DEVIATION 3.17 • n=274 Participants

PRIMARY outcome

Timeframe: Assessed at the mid-week treatment day dialysis session

Population: The per-protocol set (PPS) is a subset of patients who were randomized to the respective treatment at the mid-week treatment day dialysis session and did not have any major protocol deviations that could affect the assessment of the primary endpoint.

One mid-week treatment day dialysis session, pre-dialysis and post-dialysis. The RR was calculated using the following formula: \[(Cpre-Cpost)/Cpre\], where Cpre and Cpost were the arterial plasma concentrations of λ FLC measured pre- and post- the mid-week dialysis session, respectively

Outcome measures

Outcome measures
Measure
Theranova 400 Dialyzer
n=131 Participants
1 week, 1 mid-week HD therapy session . Theranova 400 Dialyzer: Dialysis performed in HD mode.
FX 800 Dialyzer
n=131 Participants
1 week, 1 mid-week HDF therapy session. FX 800 Dialyzer: Dialysis performed in HDF mode.
Reduction Ratio (RR) of Lambda Free Light Chains (λ FLC)
36.02 Reduction Ratio (%)
Interval 34.36 to 37.69
19.03 Reduction Ratio (%)
Interval 17.64 to 20.41

PRIMARY outcome

Timeframe: Assessed at the mid-week treatment day dialysis session

Population: The per-protocol set (PPS) was a subset of patients who were randomized to the respective treatment at the mid-week treatment day dialysis session and did not have any major protocol deviations that could affect the assessment of the primary endpoint.

One mid-week treatment day dialysis session, pre-dialysis and post-dialysis. The RR was calculated using the following formula: \[(Cpre-Cpost)/Cpre\], where Cpre and Cpost were the arterial plasma β2-MG concentrations measured pre- and post- the mid-week dialysis session, respectively.

Outcome measures

Outcome measures
Measure
Theranova 400 Dialyzer
n=131 Participants
1 week, 1 mid-week HD therapy session . Theranova 400 Dialyzer: Dialysis performed in HD mode.
FX 800 Dialyzer
n=131 Participants
1 week, 1 mid-week HDF therapy session. FX 800 Dialyzer: Dialysis performed in HDF mode.
Reduction Ratio of Beta-2 Microglobulin (β2-MG)
77.03 Reduction Ratio (%)
Interval 76.15 to 77.91
78.22 Reduction Ratio (%)
Interval 77.18 to 79.25

Adverse Events

Theranova 400 Dialyzer

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

FX 800 Dialyzer

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Theranova 400 Dialyzer
n=139 participants at risk
1 week, 1 session in mid-week HD therapy. Pre dialysis blood samples taken from fistula needle or central venous catheter. Post dialysis blood samples taken from arterial sampling port of bloodline Theranova 400 Dialyzer: Dialysis performed in HD mode.
FX 800 Dialyzer
n=135 participants at risk
1 week, 1 session in mid-week HDF therapy. Pre dialysis blood samples taken from fistula needle or central venous catheter. Post dialysis blood samples taken from arterial sampling port of bloodline FX 800 Dialyzer: Dialysis performed in HDF mode.
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
0.72%
1/139 • Number of events 1 • All treatment emergent adverse events collected from enrollment through the End of Study Visit, i.e., a follow-up visit during the end-of-week dialysis session (up to 1 week)
The safety analysis set included all enrolled patients, as treated (139 patients in the Theranova 400 group and 135 patients in the FX 800 group)
0.00%
0/135 • All treatment emergent adverse events collected from enrollment through the End of Study Visit, i.e., a follow-up visit during the end-of-week dialysis session (up to 1 week)
The safety analysis set included all enrolled patients, as treated (139 patients in the Theranova 400 group and 135 patients in the FX 800 group)

Other adverse events

Adverse event data not reported

Additional Information

Global CORP Clinical Trials Disclosure

Vantive

Phone: +1 2249484283

Results disclosure agreements

  • Principal investigator is a sponsor employee Baxter Healthcare Corporation reserves the right of prior review and approval of data from this study relative to the potential release of proprietary information to any publication or for any presentation.
  • Publication restrictions are in place

Restriction type: OTHER