Incremental Haemodialysis in Incident Patients

NCT03239808 | Active Not Recruiting

• 1 other identifier: IHDIP (P1712)
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 3

Brief Summary

Background: Incremental hemodialysis (HD) is a starting regime for renal replacement therapy (RRT) adapted to each patient's necessities. It is mainly conditioned by the residual renal function (RRF). The frequency of sessions with which patients start HD -one or two sessions per week-, is lower than that for conventional HD three times per week. Such frequency is increased (from one to two sessions, and from two to three sessions) as the RRF declines. Methods/Design: IHDIP is a multicenter randomized experimental open trial. It is randomized in a 1:1 ratio and controlled through usual clinical practice, with a low intervention level and non-commercial. It includes 152 patients older than 18 years with chronic renal disease stage 5 and start HD as RRT, with a RRF of ≥ 4ml/min/1.73m2, measured by renal clearance of urea (KrU). The intervention group includes 76 patients who will start with one session of HD per week (incremental HD). The control group includes 76 patients who will start with three sessions per week (conventional HD). The primary purpose is assessing the survival rate, while the secondary purposes are the morbidity rate (hospital admissions), the clinical parameters, the quality of life and the efficiency. Discussion: This study will enable us to know with the highest level of scientific evidence, the number of sessions a patient should receive when starting the HD treatment, depending on his/her RRF.

Conditions

Renal Disease, End-Stage

Keywords

once-weekly haemodialysis; incremental haemodialysis; randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Survival rate

  Assess and compare survival in subjects with one session a week as an RRT starting regimen, compared to those patients who start RRT with the conventional method

  24 months

Secondary Outcomes (7)

• Hospital admissions

  24 months

• Residual Kidney Function (RRF) maintenance .

  24 months

• Analysis of anemia

  3, 6, 9, 12, 18 and 24 months

• Bone-mineral metabolism

  3, 6, 9, 12, 18 and 24 months

• Hypertrophic cardiomyopathy levels

  Basal, anual and end of the follow-un visit

Study Arms (2)

Experimental group

EXPERIMENTAL

76 patients who start RRT with the incremental HD regimen.

Procedure: Incremental haemodialysis

Control group

ACTIVE COMPARATOR

76 patients who start RRT with the conventional HD (3 sessions per week)

Procedure: Conventional haemodialysis

Interventions

Incremental haemodialysis PROCEDURE

It consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression

Experimental group

Conventional haemodialysis PROCEDURE

It is controlled through usual clinical practice, based on starting the HD treatment with three sessions per week (control group).

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged \>18 years, incident patients with stage 5 CKD who have chosen HD as RRT initiation.
• RRF measured by KrU ≥ 4 ml/min/1.73m2. In general, it is advised not to start HD with a KrU\> 7.
• Informed consent signed before starting any activity related to the trial.

You may not qualify if:

• Unplanned HD initiation (established in point 7.4 of the protocol)
• Non incident patients, in other words, patients who were previously on RRT, either on peritoneal dialysis, or on kidney transplant.
• Cardiovascular disease defined as: heart failure type IV of the New York Heart Association (NYHA), unstable angina or ischemic cardiopathy which has caused any admission in hospital in the last 3 months.
• Cardiorenal syndrome
• Active inflammatory disease with immunosuppressive treatment
• Hepatorenal syndrome

Sponsors & Collaborators

• Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura: lead
• Hospital Arquitecto Marcide. Ferrol. A Coruña. (Spain): collaborator
• Hospital San Pedro de Alcantara: collaborator
• Virgen del Puerto Hospital: collaborator
• Hospital Central de la Defensa Gómez Ulla. Madrid (Spain): collaborator
• Hospital Costa del Sol: collaborator
• Hospital Obispo Polanco. Teruel (Spain): collaborator
• Hospital de Manises. Valencia (Spain): collaborator
• Hospital Virgen de la Concha. Zamora (Spain): collaborator
• Hospital de Especialidades de las Fuerzas Armadas. Quito (Ecuador): collaborator
• Servicio Extremeño de Salud (Spain): collaborator
• Hospital del SAS de Jerez: collaborator
• Hospital Nuestra Sra de Sonsoles. Ávila (Spain): collaborator
• Dialysis Center SM2. Potenza (Italy): collaborator
• Miulli General Hospital: collaborator
• Hospital del Rio Hortega: collaborator
• Hospital Duran de Buenos Aires: collaborator
• Hospital El Bierzo: collaborator
• Hospitales Universitarios Virgen del Rocío: collaborator
• Hospital Universitario Virgen Macarena: collaborator
• University Hospital of Girona Dr. Josep Trueta: collaborator

Study Sites (3)

FundeSalud. Junta de Extremadura

Mérida, Badajoz, 06800, Spain

Location

Hospital Virgen del Puerto

Plasencia, Cáceres, 10600, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, 10003, Spain

Location

Related Publications (25)

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MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Javier L Deira Lorenzo, PhD MD

  Servicio Extremeño de Salud

  PRINCIPAL INVESTIGATOR

• Miguel A Suarez Santisteban, MD

  Servicio Extremeño de Salud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, multicenter, randomized clinical trial. It has two strata: for age (≥or\< 75 years old) and for KrU (≥or\< 5,5 ml/min/1.73m2). It is controlled through usual clinical practice. Intervention consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression.

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: August 4, 2017
• Study Start: March 14, 2018
• Primary Completion: June 6, 2024
• Study Completion: June 30, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

ES (3)