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Tests treatment safety and results for End Stage Renal Disease on Dialysis
Official title RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis (REAL-LIFE)
ClinicalTrials.gov ID: NCT04360694
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bari, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bari, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.