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Incremental Haemodialysis in Incident Patients (IHDIP)

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ClinicalTrials.gov Identifier: NCT03239808
Recruitment Status : Recruiting
First Posted : August 4, 2017
Last Update Posted : April 13, 2018
Sponsor:
Collaborators:
Hospital Arquitecto Marcide. Ferrol. A Coruña. (Spain)
Hospital Clínico Universitario. Santiago de Compostela. A Coruña (Spain)
Hospital San Pedro de Alcantara. Cáceres (Spain)
Virgen del Puerto Hospital
Hospital Central de la Defensa Gómez Ulla. Madrid (Spain)
Hospital Costa del Sol
Hospital Obispo Polanco. Teruel (Spain)
Hospital de Manises. Valencia (Spain)
University of Salamanca
Hospital Virgen de la Concha. Zamora (Spain)
Hospital de Especialidades de las Fuerzas Armadas. Quito (Ecuador)
Servicio Extremeño de Salud (Spain)
Hospital del SAS de Jerez
Hospital Nuestra Sra de Sonsoles. Ávila (Spain)
Dialysis Center SM2. Potenza (Italy)
Miulli General Hospital
Information provided by (Responsible Party):
Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura

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.


Condition or disease Intervention/treatment Phase
Renal Disease, End-Stage Procedure: Incremental haemodialysis Procedure: Conventional haemodialysis Not Applicable

Detailed Description:

Conventional thrice-weekly HD for 3 to 5 hours in a health center in an outpatient basis is the most used renal replacement therapy (RRT) regimen (1). However, it has an unacceptable high mortality rate (10%-20% a year). In order to try to improve those results, new regimens have been proposed. They are based on an increase of the HD dose and/or a higher number of sessions (2). Nevertheless, inconsistent results in terms of clinical benefits with such programs have been shown in recently published randomized and controlled trials (3,4), together with a lower rate of vascular access success (5) and a lower maintenance of the RRF (6) The National Kidney Foundation-Kidney Disease Outcomes Quality Initiate (NKD KDOQI 2015)(1) 2015 guidelines allow the reduction in the weekly HD dose for patients with a residual kidney urea clearance (KrU) higher than 3ml/min/1.73m2. In these cases, the renal clearance (Kr) is added to the dialysis clearance (Kd) obtained in 2 sessions per week, thus obtaining the adequate dialysis dose (7,8) Surprisingly enough, few centers follow this recommendation when over 50% of patients start HD with KrU >3 mL/min (9).

Authors like Kalantar-Zadeh et al (9,10) in the U.S.A. or Teruel et al (11) in Spain have published their experience with 2 HD sessions per week in incident patients. Through this regime they have shown that the RRF is preserved and the survival rate is similar to the one obtained with the conventional HD. This is due to the fact that the Kr has much greater clinical weight than Kd7, since the RRF contributes to the production of vitamin D and erythropoietine (12,13), and eliminates the protein-bound uremic toxins that are poorly dialyzed (13,14). In other words, the RRF plays a fundamental role both in the dialysis adequacy and in survival (15,16).

Currently, some authors are questioning the number of HD sessions with which a patient should start the renal replacement therapy (RRT) (7, 17-19). Progressive HD is an initiation regimen adapted to the patient's RRF. The frequency increases as the daily diuretic level declines (7, 17-19).

The IHDIP trial20 aims at determining whether or not starting with one HD session per week reduces mortality in incident patients and its influence in morbidity (hospital admissions), clinical parameters, quality of life and efficiency with regard to the patients who start RRT with the conventional method.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a prospective, multicenter, randomized clinical trial. It has two strata: for age (≥or< 75 years old) and for KrU21 (≥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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Incremental Haemodialysis Security and Effectiveness in Incident Patients
Actual Study Start Date : March 14, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Experimental group
76 patients who start RRT with the incremental HD regimen.
Procedure: Incremental haemodialysis
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

Active Comparator: Control group
76 patients who start RRT with the conventional HD (3 sessions per week)
Procedure: Conventional haemodialysis
It is controlled through usual clinical practice, based on starting the HD treatment with three sessions per week (control group).




Primary Outcome Measures :
  1. Survival rate [ Time Frame: 24 months ]
    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


Secondary Outcome Measures :
  1. Hospital admissions [ Time Frame: 24 months ]
    Number of hospitalizations, for any cause; and number of days hospitalized for any cause

  2. Residual Kidney Function (RRF) maintenance . [ Time Frame: 24 months ]
    Reduction of glomerular filtration rate (GFR) and tubular function. Average urine volume and percentage of patients with anuria (≤200ml/day in two consecutive measurements).

  3. Analysis of anemia [ Time Frame: 3, 6, 9, 12, 18 and 24 months ]
    Mean hemoglobin levels and Proportion of patients with Hb measurement inside the target range (10.5-12 g/dl) and The erythropoietin resistance index (ERI): ERI = weekly EPO (in UI)/patient's weight (in kg)/Hb (in gr/dl)

  4. Bone-mineral metabolism [ Time Frame: 3, 6, 9, 12, 18 and 24 months ]
    Mean levels of calcium, phosphorus and intac PTH levels. Estimate the percentage of patients within the therapeutic range; Calcium 8,4-9,5mg/dl, Phosphorus 3,5-5,5mg/dl and iPTH 150-300 pg/dl.

  5. Hypertrophic cardiomyopathy levels [ Time Frame: Basal, anual and end of the follow-un visit ]
  6. Estimation of the effect of treatment on quality of life [ Time Frame: 3, 6, 9, 12, 18 and 24 months ]
    Quality of life survey values from Kidney Disease and Quality of Life (KDQOL'36 Spanish) will be registered.

  7. Assessing RRT efficiency (costs) [ Time Frame: 12 and 24 months ]
    The number of sessions perform in subjects of incremental HDF group Vs number of sessions in the conventional HD group. The cost of each session is defined by the public contest for private haemodialysis clinics arranged by (that work to) the Health Service of Extremadura.



Information from the National Library of Medicine

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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:

  • 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.

Exclusion Criteria:

  • 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.
  • Active neoplasia at the moment of inclusion
  • 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

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): NCT03239808


Contacts
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Contact: Javier L Deira Lorenzo, PhD MD +34-661374085 deiralorenzo@gmail.com
Contact: Miguel A Suarez Santisteban, MD +34-617426612 santisteban79@gmail.com

Locations
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Spain
FundeSalud. Junta de Extremadura Recruiting
Mérida, Badajoz, Spain, 06800
Contact: Jonathan Gómez Raja, PhD    +34-924009306    jonathan.gomez@fundesalud.es   
Contact: Maria Isabel Cotilla    +34-924004354    misabel.cotilla@fundesalud.es   
Hospital Virgen del Puerto Recruiting
Plasencia, Cáceres, Spain, 10600
Contact: Miguel A Suarez Santisteban, MD    +34-617426612    santisteban79@gmail.com   
Principal Investigator: Miguel A Suarez Santisteban, MD         
Hospital San Pedro de Alcántara Recruiting
Cáceres, Spain, 10003
Contact: Javier L Deira Lorenzo, PhD MD    +34-661374085    deiralorenzo@gmail.com   
Principal Investigator: Javier L Deira Lorenzo, PhD MD         
Sponsors and Collaborators
Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
Hospital Arquitecto Marcide. Ferrol. A Coruña. (Spain)
Hospital Clínico Universitario. Santiago de Compostela. A Coruña (Spain)
Hospital San Pedro de Alcantara. Cáceres (Spain)
Virgen del Puerto Hospital
Hospital Central de la Defensa Gómez Ulla. Madrid (Spain)
Hospital Costa del Sol
Hospital Obispo Polanco. Teruel (Spain)
Hospital de Manises. Valencia (Spain)
University of Salamanca
Hospital Virgen de la Concha. Zamora (Spain)
Hospital de Especialidades de las Fuerzas Armadas. Quito (Ecuador)
Servicio Extremeño de Salud (Spain)
Hospital del SAS de Jerez
Hospital Nuestra Sra de Sonsoles. Ávila (Spain)
Dialysis Center SM2. Potenza (Italy)
Miulli General Hospital
Investigators
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Principal Investigator: Javier L Deira Lorenzo, PhD MD Servicio Extremeño de Salud
Principal Investigator: Miguel A Suarez Santisteban, MD Servicio Extremeño de Salud
  Study Documents (Full-Text)

Documents provided by Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura:
Informed Consent Form  [PDF] March 10, 2017


Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
ClinicalTrials.gov Identifier: NCT03239808     History of Changes
Other Study ID Numbers: IHDIP (P1712)
First Posted: August 4, 2017    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura:
once-weekly haemodialysis
incremental haemodialysis
randomized clinical trial
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency