NCT05828823 Incremental Hemodialysis: The TwoPlus Trial
| NCT ID | NCT05828823 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | End-Stage Kidney Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2024-02-26 |
| Primary Completion | 2030-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 350 participants in total. It began in 2024-02-26 with a primary completion date of 2030-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is to prospectively compare clinical effectiveness between clinically- matched incremental hemodialysis and conventional hemodialysis in patients with incident kidney dysfunction requiring dialysis and residual kidney function. The study will enroll 350 patients on chronic hemodialysis and 140 caregivers of enrolled patients. Patients will be randomized in 1:1 ratio to either incremental start hemodialysis or conventional hemodialysis. Caregivers will be followed along with patients for an average period of 2 years post randomization.
Eligibility Criteria
Patient eligibility Criteria: Inclusion Criteria: * Clinical Inclusion Criteria: * Age ≥ 18 years * Incident kidney dysfunction requiring dialysis (KDRD) started on maintenance, in-center hemodialysis (HD), or anticipated to be started on maintenance, in-center HD within the next 12 weeks * Has received ≤36 sessions of intermittent HD (i.e., on HD for ≤12 weeks) at the time patient is approached for potential study participation Residual Kidney Function Inclusion Criteria: * Kidney urea clearance ≥ 2.0 mL/min * Urine volume# of ≥500 mL/24 h Exclusion Criteria: * Pre-HD serum K ≥5.8 mEq/L, Na ≤125 mEq/L, or bicarbonate level ≤17 mEq/L * Requirement or anticipated requirement of high-volume ultrafiltration * Unable or unwilling to follow the study protocol for any reason * Known pregnancy or planning to attempt to become pregnant or lactating women * Estimated survival or dialysis modality change or center transfer \<6 months Caregiver Eligibility Criteria: * be at least 18 years old * be the main caregiver (at patient's choice) * be a close relative of the patient (spouse, child, sibling, parent, grandchild) * have no known psychiatric and neurologic disorders (through direct inquiry from the person) * not be a member of the medical or healthcare team * not be the caregiver for another patient with chronic illness * not have experienced severe life events within prior 3 months of enrollment (through direct inquiry from the person)
Contact & Investigator
Mariana Murea, MD
PRINCIPAL INVESTIGATOR
Wake Forest Health Sciences
Frequently Asked Questions
Who can join the NCT05828823 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying End-Stage Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05828823 currently recruiting?
Yes, NCT05828823 is actively recruiting participants. Contact the research team at Brindusa.Burciu@advocatehealth.org for enrollment information.
Where is the NCT05828823 trial being conducted?
This trial is being conducted at Jacksonville, United States, Atlanta, United States, Baltimore, United States, Boston, United States and 6 additional locations.
Who is sponsoring the NCT05828823 clinical trial?
NCT05828823 is sponsored by Wake Forest University Health Sciences. The principal investigator is Mariana Murea, MD at Wake Forest Health Sciences. The trial plans to enroll 350 participants.
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