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Trial record 60 of 2249 for:    Recruiting, Not yet recruiting, Available Studies | Renal

Incremental Hemodialysis as a Starting Way of Renal Replacement Therapy

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ClinicalTrials.gov Identifier: NCT03302546
Recruitment Status : Recruiting
First Posted : October 5, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Tracking Information
First Submitted Date  ICMJE July 3, 2017
First Posted Date  ICMJE October 5, 2017
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE April 4, 2017
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2017)
Asses the loss of residual renal function in patients who started chronic hemodialysis [ Time Frame: Measurements of multiple variables to measure renal function each two months during one year period ]
Assess the loss of renal function evolution in patients starting hemodialysis therapy 2 days per week, versus patients with hemodialysis 3 days per week.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03302546 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Incremental Hemodialysis as a Starting Way of Renal Replacement Therapy
Official Title  ICMJE Incremental Hemodialysis as a Starting Way of Renal Replacement Therapy
Brief Summary

The Hemodialysis Unit of the Hospital Ramon y Cajal is a pioneer in the implementation of a program of incremental hemodialysis, starting with two sessions a week in patients with residual renal function.

The main objective is to compare whether the initiation of hemodialysis with two sessions a week over conventional pattern of initiation of three sessions a week better preserves residual renal function.

Detailed Description

The primary specific objective is to assess the loss of renal function defined as 24 hours diuresis less than 100 ml at 12 months of starting treatment. Secondary objectives are: erythropoietin dose, concentration of beta 2-microglobulin, p-cresol, fenol, the state of hydration and nutrition, adverse effects, hospital admissions, mortality and quality of life, comparing both arms of treatment.

DESIGN: Multicenter randomized clinical trial. Randomization will be performed by an external agent that guarantees an homogeneous balance between both arms. The randomization sequence will not be available for the investigators responsible of the patients.

Inclusion criteria: Patients starting hemodialysis that maintain residual diuresis and urea clearance greater than or equal to 2.5 ml / min with a minimum follow-up of one year.

Exclusion criteria: Anuric patients, patients with acute renal failure and patients who start hemodialysis after having going through a renal transplant.

The variables that will be analyzed are 24h diuresis, urea clearance, creatinin clearance, haemoglobin, leukocytes, platelets, creatinin, urea, Na, K, albumin, prealbumin, Ca, P, PTH, PCR, ferritin, B2microglobulin, BNP, KT/V, Erythropoietin dose, state of hydratation and life quality.

Sample size should be of 42 patients on each arm of treatment to obtain a 95% confidence (α=0,05) and a 80% of statistical power (β=0,20).

The normality of the data will be analyzed with Kolmogorov-Smirnov test which will allow to use parametric tests (T-student) or non-parametric tests (U-Mann-Whitney). Association of categoric variables of both arms will be analyzed with Chi2 test, or using Fisher statistic.

Loss of renal function will be analyzed up to 12 months and time studies will be performed through non-parametric test (Kaplan-Meier), obtaining the estimated probability of loss of renal function in both arms and comparing survival functions through "Log-Rank" statistic.

The demonstration of efficacy and safety through a clinical trial would spread this clinical practice in the nephrology community and therefore in our national health system.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Renal Failure
Intervention  ICMJE
  • Procedure: Incremental hemodialysis
    Patients randomized to this arm of treatment will be treated during at least 4 hours of hemodialysis twice per week
  • Procedure: Conventional hemodialysis
    Patients randomized to this arm of treatment will be treated during at least 3.5 hours of hemodialysis three times per week
Study Arms  ICMJE
  • Active Comparator: Incremental Hemodialysis
    Subjects on this arm will be treated with 2 hemodialysis sessions of at least 4 hour per week.
    Intervention: Procedure: Incremental hemodialysis
  • Active Comparator: Conventional hemodialysis
    Subjects on this arms will be treated with 3 hemodialysis sessions of at least 3.5 hour per week.
    Intervention: Procedure: Conventional hemodialysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 4, 2017)
7
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects starting renal replacement therapy from January 2017 to June 2018.
  • Subjects who consent to sign the Informed Consent Form.
  • Subject who maintain residual diuresis and urea clearance equal or superior to 2,5 ml/min.

Exclusion Criteria:

  • Anuric patients.
  • Patients with acute renal failure.
  • Patients who revoke the Informed Consent Form.
  • Patients who start hemodialysis after having going through a renal transplant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Milagros Fernández-Lucas, MD 913368810 milagros.fernandez@salud.madrid.org
Contact: Andrea Collado, PhD 913368018 andrea.collado@salud.madrid.org
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03302546
Other Study ID Numbers  ICMJE 034/17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study Sponsor  ICMJE Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP