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Trial record 61 of 2242 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

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.


Condition or disease Intervention/treatment Phase
Chronic Renal Failure Procedure: Incremental hemodialysis Procedure: Conventional hemodialysis Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Incremental Hemodialysis as a Starting Way of Renal Replacement Therapy
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: Incremental Hemodialysis
Subjects on this arm will be treated with 2 hemodialysis sessions of at least 4 hour per week.
Procedure: Incremental hemodialysis
Patients randomized to this arm of treatment will be treated during at least 4 hours of hemodialysis twice per week

Active Comparator: Conventional hemodialysis
Subjects on this arms will be treated with 3 hemodialysis sessions of at least 3.5 hour 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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302546


Contacts
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Contact: Milagros Fernández-Lucas, MD 913368810 milagros.fernandez@salud.madrid.org
Contact: Andrea Collado, PhD 913368018 andrea.collado@salud.madrid.org

Locations
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Spain
Hospital Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: Milagros Fernández-Lucas, MD    913368810    milagros.fernandez@salud.madrid.org   
Contact: Andrea Collado, PhD    913368018    andrea.collado@salud.madrid.org   
Principal Investigator: Milagros Fernández-Lucas, MD         
Sub-Investigator: Gloria Ruiz-Roso, MD         
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT03302546     History of Changes
Other Study ID Numbers: 034/17
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic