Incremental Hemodialysis as a Starting Way of Renal Replacement Therapy

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

Tracking Information

• First Submitted Date: July 3, 2017
• First Posted Date: October 5, 2017
• Last Update Posted Date: February 15, 2019
• Actual Study Start Date: April 4, 2017
• Estimated Primary Completion Date: December 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT03302546 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Incremental Hemodialysis as a Starting Way of Renal Replacement Therapy
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Renal Failure

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 4, 2017): 7
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2020
• Estimated Primary Completion Date: December 30, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Milagros Fernández-Lucas, MD; 913368810; milagros.fernandez@salud.madrid.org

Contact: Andrea Collado, PhD; 913368018; andrea.collado@salud.madrid.org

• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT03302546
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Study Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Verification Date: February 2019