Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT04786535
Status:
UNKNOWN
Last Update Posted:
2021-09-17
First Post:
2021-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Uremic Toxins Clearance With Expanded Hemodialysis
Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Organization:
Study Overview
Official Title:
Crossover Study of Three Groups Comparing the Efficacy of Uremic Toxins Clearance of Expanded Hemodialysis With Two Hemodialysis Membranes for Conventional Hemodialysis and Hemodiafiltration
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to quantify the B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx (expanded hemodialysis), HDc (high-flux conventional hemodialysis), or HDF (hemodiafiltration).
And to compare the magnitude of the B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx, HDc, or HDF
And to compare the magnitude of the B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx, HDc, or HDF
Detailed Description:
A controlled, randomized, crossover clinical trial is planned to compare the magnitude of the B2-microglobulin reduction rate in three different extracorporeal therapies (ETs): HDc, HDx, and HDF.
The selection of study participants will be consecutive and for convenience
This study will be divided into six periods: three treatment periods (one for each therapy to be compared) and three of "washout" periods (interspersed between the treatment periods). The treatment periods will last four weeks (12 ET sessions, three per week) and will be preceded by a one-week washout period (three ET sessions)
After inclusion in the protocol, participants will be randomly assigned (with the help of a table of random numbers) to one of three ETs to be evaluated (HDc, HDx, or HDF). Afterwards, the first washout period will begin with high-flow conventional hemodialysis (HDc). At the end of the first washout period, the ET randomly assigned to one of three ETs to be evaluated (HDc, HDx, or HDF), following the sequence: Washout 1 -\> Period 1 (HDC, HDx, or HDF) -\> Washout 2 -\> Period 2, etc.
For each period of ET, there will be two sampling times: baseline and final
Blood samples will be obtained through the arterial port of the extracorporeal circuit, at the beginning and at the end of the ET session. The "slow flow" method will be used (UF: 0 mL/min, Qd: 0 mL/min, and Qb: 100 mL/min, for 30 seconds, before extracting the sample from the arterial port) (24). Blood samples will be collected in dry tubes (without anticoagulant) and centrifuged for 10 minutes at 3,000 RPM. The supernatant will be divided into three aliquots and stored at -70°C for further processing.
To calculate sample size, the formula for a noninferiority study was used (Pharmaceutical statistics. 2016;15(1):80-9), which is detailed below:
n= ((r+1) (Z\_(1-β)+Z\_(1-α) )\^2 σ\^2)/(r((μ\_A-μ\_B )-d\_NI )\^2 )
The terms above, are substituted with values obtained from the publication of Kirsch et al. (Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172) as follows:
Objective: Non-inferiority (Ho µA - µB ≤ -dNI vs. µA - µB \> -dNI) Outcome: B2-microglobulin reduction rate. r: allocation ratio by group:1 beta: type II error (90% power):1.2816 alpha: type I error (level of significance 5%):1.960 (variance in the population):1.33 µA - µB (magnitude of the observed effect):80.6 - 78.5 = 2.1 dNI (non-inferiority limit): 3.5
n= ((1+1) (1.2816+1.960)\^2 〖(1.33)〗\^2)/(1((2.1)-3.5)\^2 )= 19, the investigators estimate a 20 % loss in the follow-up , then investigators consider a sample size of n = 23 patients
The nominal variables will be presented in frequencies and proportions. Continuous numerical variables will be analyzed using the Kolmogorov-Smirnov "Z" test to determine their distribution. The results will be shown as the means ± standard deviation in case of normal distribution and as a median with minimum and maximum limits for variables with non-normal distribution.
The total serum concentration of the biochemical variables in general as well as the uremic toxins will be analyzed. Additionally, the reduction rate and purification of the uremic toxins will be analyzed.
The analyses of the inter- and intra-group differences will be performed using the one-way multiple comparisons (ANOVA) method. Post hoc analysis using the Bonferroni method will be used in cases where the groups present a normal distribution; otherwise, the Kruskal-Wallis method will be used. A result with a p \< 0.05 will be considered significant
The selection of study participants will be consecutive and for convenience
This study will be divided into six periods: three treatment periods (one for each therapy to be compared) and three of "washout" periods (interspersed between the treatment periods). The treatment periods will last four weeks (12 ET sessions, three per week) and will be preceded by a one-week washout period (three ET sessions)
After inclusion in the protocol, participants will be randomly assigned (with the help of a table of random numbers) to one of three ETs to be evaluated (HDc, HDx, or HDF). Afterwards, the first washout period will begin with high-flow conventional hemodialysis (HDc). At the end of the first washout period, the ET randomly assigned to one of three ETs to be evaluated (HDc, HDx, or HDF), following the sequence: Washout 1 -\> Period 1 (HDC, HDx, or HDF) -\> Washout 2 -\> Period 2, etc.
For each period of ET, there will be two sampling times: baseline and final
Blood samples will be obtained through the arterial port of the extracorporeal circuit, at the beginning and at the end of the ET session. The "slow flow" method will be used (UF: 0 mL/min, Qd: 0 mL/min, and Qb: 100 mL/min, for 30 seconds, before extracting the sample from the arterial port) (24). Blood samples will be collected in dry tubes (without anticoagulant) and centrifuged for 10 minutes at 3,000 RPM. The supernatant will be divided into three aliquots and stored at -70°C for further processing.
To calculate sample size, the formula for a noninferiority study was used (Pharmaceutical statistics. 2016;15(1):80-9), which is detailed below:
n= ((r+1) (Z\_(1-β)+Z\_(1-α) )\^2 σ\^2)/(r((μ\_A-μ\_B )-d\_NI )\^2 )
The terms above, are substituted with values obtained from the publication of Kirsch et al. (Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172) as follows:
Objective: Non-inferiority (Ho µA - µB ≤ -dNI vs. µA - µB \> -dNI) Outcome: B2-microglobulin reduction rate. r: allocation ratio by group:1 beta: type II error (90% power):1.2816 alpha: type I error (level of significance 5%):1.960 (variance in the population):1.33 µA - µB (magnitude of the observed effect):80.6 - 78.5 = 2.1 dNI (non-inferiority limit): 3.5
n= ((1+1) (1.2816+1.960)\^2 〖(1.33)〗\^2)/(1((2.1)-3.5)\^2 )= 19, the investigators estimate a 20 % loss in the follow-up , then investigators consider a sample size of n = 23 patients
The nominal variables will be presented in frequencies and proportions. Continuous numerical variables will be analyzed using the Kolmogorov-Smirnov "Z" test to determine their distribution. The results will be shown as the means ± standard deviation in case of normal distribution and as a median with minimum and maximum limits for variables with non-normal distribution.
The total serum concentration of the biochemical variables in general as well as the uremic toxins will be analyzed. Additionally, the reduction rate and purification of the uremic toxins will be analyzed.
The analyses of the inter- and intra-group differences will be performed using the one-way multiple comparisons (ANOVA) method. Post hoc analysis using the Bonferroni method will be used in cases where the groups present a normal distribution; otherwise, the Kruskal-Wallis method will be used. A result with a p \< 0.05 will be considered significant
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: