Incremental hemodialysis for patients with end-stage renal disease
RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis
This study is testing if a new way of doing hemodialysis, which adjusts treatment based on how well your kidneys still work, can help people with end-stage renal disease feel better and stay healthier compared to the usual treatment schedule.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari Academic / other |
| Locations | 1 site (Bari) |
| Trial ID | NCT04360694 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of incremental hemodialysis compared to the standard thrice-weekly hemodialysis regimen for patients with end-stage renal disease. The study utilizes a Variable Target Model that adjusts dialysis frequency based on residual kidney function, allowing for potentially less frequent treatments. It is a pragmatic, multicenter, open-label randomized controlled trial designed to assess various outcomes, including kidney function preservation and cardiovascular health. The trial aims to provide clearer standards for incorporating residual kidney function into dialysis treatment plans.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are starting or have recently started maintenance hemodialysis due to advanced chronic kidney disease.
Not a fit: Patients with acute kidney injury, those with a glomerular filtration rate above 10 mL/min/1.73 m2, or those already receiving other forms of dialysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved kidney function preservation and better overall health outcomes for patients on hemodialysis.
How similar studies have performed: While observational studies have shown promise for incremental hemodialysis, this randomized controlled trial is among the first to rigorously test this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bari
- Azienda Ospedaliero Universitaria Consorziale Policlinico — Bari, Italy (Recruiting)
Study contacts
- Study coordinator: Loreto Gesualdo, MD
- Email: loreto.gesualdo@uniba.it
- Phone: +390805594041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.