End Stage Renal Disease on Dialysis Clinical Trial
Official title:
RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis
Background: The thrice-weekly hemodialysis (HD) regimen is widely accepted as a standard prescription. The concept of incremental dialysis has been established as a possible alternative for patients with preserved diuresis and end-stage renal failure in need of HD. The main problems related to prescription of incremental HD are an arbitrary use of infrequent regimens and the lack of clear standards for incorporating residual kidney function (RKF) in the assessment of HD dose. Several models have been proposed for prescription of incremental dialysis. The latest, the variable target model (VTM), gives more clinical weight to the RKF and allows less frequent HD treatments at lower RKF. Despite increasing evidence derived from observational studies to support the use of incremental HD, RCTs are lacking and, therefore, urgently needed. Methods/Design: The Department of Nephrology, Dialysis and Transplantation of the Azienda Ospedaliero Universitaria Consorziale Policlinico, Bari, Italy and the EUDIAL Working Group of the European Renal Association - European Dialysis Transplant Association (ERA-EDTA) are starting a randomized clinical trial (RCT) in incident HD patients, whose name is "REAL LIFE", by using the acronym of its whole definition: RandomizEd clinicAL triaL on the effIcacy and saFety of incremental haEmodialysis. REAL LIFE is a pragmatic, prospective, multicentre, open label RCT, investigator-initiated, comparing the intervention arm (incremental HD) with the control arm (standard 3HD/wk). The trial, originally conceived by experts at the Division of Nephrology of the Miulli General Hospital, Acquaviva delle Fonti, Italy, consists in starting the HD treatment adopting the new incremental approach guided by the VTM. The primary outcome is the survival of kidney function, with the event defined as urinary output (UO) ≤ 200 mL/day, confirmed by a further collection after 2 weeks to exclude temporary illness. Discussion: REAL LIFE will enable the investigators to know with the highest level of scientific evidence the safety and efficacy of an incremental approach to the start of HD treatment.
Status | Recruiting |
Enrollment | 190 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults aged > 18 years - Start of maintenance hemodialysis treatment due to advanced CKD stage 5D - Patients who are about to start HD or have already started HD within a period of = 2 weeks - Glomerular filtration rate <= 10 mL/min/1.73 m2, as estimated by means of CKD-EPI formula. Exclusion Criteria: - Age < 18 years - Acute kidney injury or acute on chronic kidney injury - eGFR higher than 10 mL/min/1.73 m2 - UO < 600 mL/day - Already treated with other replacement therapies (peritoneal dialysis or kidney transplant) - Unable or unwilling to give informed consent. - Unable to comply with trial procedures, e.g., collection of UO. - Likely survival prognosis or planned modality or centre transfer < 6 months. - Patients who are in the waiting list for a living kidney transplant - Associated diseases: active neoplastic disease; refractory congestive heart failure (type IV NYHA, ejection fraction = 30%) requiring high ultrafiltration volumes per session. |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero Universitaria Consorziale Policlinico | Bari |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari | European Renal Association - European Dialysis and Transplant Association |
Italy,
Basile C, Casino FG, Kalantar-Zadeh K. Is incremental hemodialysis ready to return on the scene? From empiricism to kinetic modelling. J Nephrol. 2017 Aug;30(4):521-529. doi: 10.1007/s40620-017-0391-0. Epub 2017 Mar 23. — View Citation
Basile C, Casino FG; EUDIAL Working Group of ERA-EDTA. Incremental haemodialysis and residual kidney function: more and more observations but no trials. Nephrol Dial Transplant. 2019 Nov 1;34(11):1806-1811. doi: 10.1093/ndt/gfz035. No abstract available. — View Citation
Casino FG, Basile C. A user-friendly tool for incremental haemodialysis prescription. Nephrol Dial Transplant. 2018 Jun 1;33(6):1074-1075. doi: 10.1093/ndt/gfy081. No abstract available. — View Citation
Casino FG, Basile C. The variable target model: a paradigm shift in the incremental haemodialysis prescription. Nephrol Dial Transplant. 2017 Jan 1;32(1):182-190. doi: 10.1093/ndt/gfw339. — View Citation
Casino FG, Lopez T. The equivalent renal urea clearance: a new parameter to assess dialysis dose. Nephrol Dial Transplant. 1996 Aug;11(8):1574-81. — View Citation
Teruel-Briones JL, Fernandez-Lucas M, Rivera-Gorrin M, Ruiz-Roso G, Diaz-Dominguez M, Rodriguez-Mendiola N, Quereda-Rodriguez-Navarro C. Progression of residual renal function with an increase in dialysis: haemodialysis versus peritoneal dialysis. Nefrolo — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants whose kidney function remains >200 ml | The survival of kidney function is defined as a time to the event (anuria): the anuria is defined as urinary output (UO) = 200 mL/day, confirmed by a further collection after 2 weeks to exclude temporary illness | 24 months | |
Secondary | Number of participants who develop cardiovascular death, non fatal myocardial infarction and/or or non fatal stroke (composite outcome) | Cardiovascular death, non fatal myocardial infarction and/or or non fatal stroke | 24 months | |
Secondary | Mean value of intima-media thickness of the carotid arteries of participants at end of treatment and change from beginning to end of treatment | Echographic evaluation of intima-media thickness of the carotid arteries | 12 and 24 months | |
Secondary | Value of left ventricular ejection fraction established with cardiac ultrasound at end of treatment and change from beginning to end of treatment | Ecocardiography reporting data on the left ventricular ejection fraction (LVEF) | 12 and 24 months | |
Secondary | Value of residual kidney function (RKF) preservation established by the slope of decline of residual renal urea clearance | The rate of decline in RKF defined as the slope of decline of residual renal urea clearance | 24 months | |
Secondary | Number of people who die | The follow-up time will be determined in days. It will be defined as the difference in days from the date of the end of the follow-up minus the date of the baseline visit. Events will be counted either as deaths (follow-up of less than 24 months) or as end of the follow-up | 24 months | |
Secondary | Number of people who are hospitalized | The number of admissions will be registered. | 24 months | |
Secondary | Value of hemoglobin in participants at end of treatment and change from beginning to end of treatment | The hemoglobin levels (in g/dl) will be measured. | Every month | |
Secondary | Value of serum phosphorus, calcium and parathyroid hormone in participants at end of treatment and change from beginning to end of treatment | Serum phosphorus and calcium levels (in mg/dl), and intact PTH (in pg/dl) will be measured. | Every month and three months | |
Secondary | Value of serum beta 2 microglobulin (middle molecule) at end of treatment and change from beginning to end of treatment | The rate of change in serum beta 2 microglobulin in time will be evaluated | Every three months | |
Secondary | Value of p-cresyl sulfate and inoxyl sulfate at end of treatment and change from beginning to end of treatment (uraemic toxins variation) | Variation of uremic toxins including p-cresyl sulfate and inoxyl sulfate | Every six months |
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