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Serum Phosphate Targets for Hemodialysis Patients

N/A
Waitlist Available
Led By Myles Wolf, MD, MMSc
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months
Awards & highlights

Study Summary

This trial is testing the hypothesis that less stringent control of serum phosphate will result in improved outcomes for patients with ESRD undergoing hemodialysis.

Who is the study for?
The HiLo trial is for adults over 18 who have been on thrice-weekly in-center hemodialysis for at least three months. It's not suitable for those undergoing nocturnal dialysis, individuals with calciphylaxis, or pregnant women.Check my eligibility
What is being tested?
This study compares two serum phosphate level targets in patients on hemodialysis: a standard target of <5.5 mg/dl and a less strict target of >6.5 mg/dl. The goal is to see if higher targets reduce death and hospitalization rates.See study design
What are the potential side effects?
While the trial itself doesn't introduce new medications that could cause side effects, regular risks associated with hemodialysis may include low blood pressure, muscle cramps, itching, sleep problems, and anemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hierarchical Composite Mortality and all cause hospitalization
Secondary outcome measures
Time to all-cause mortality
Total Inpatient Hospital Days
all-cause hospitalization rate
+2 more

Side effects data

From 2021 Phase 3 trial • 51 Patients • NCT03740048
41%
hospitalization
5%
Hospitalization
100%
80%
60%
40%
20%
0%
Study treatment Arm
Conventional Hemodialysis Regimen
Hemodialysis and Pharmacologic Therapy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Hi ArmExperimental Treatment1 Intervention
Patients to allow blood serum phosphate levels to rise to 6.5 mg/dl or above
Group II: Lo ArmActive Control1 Intervention
Patients to titrate blood serum phosphate levels to the standard <5.5mg/dl
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hemodialysis
2008
Completed Phase 4
~1900

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,353 Previous Clinical Trials
3,407,422 Total Patients Enrolled
1 Trials studying Death
343 Patients Enrolled for Death
Northwestern UniversityOTHER
1,579 Previous Clinical Trials
916,611 Total Patients Enrolled
4 Trials studying Death
6,292 Patients Enrolled for Death
Davita Clinical ResearchIndustry Sponsor
22 Previous Clinical Trials
14,691 Total Patients Enrolled

Media Library

Hemodialysis (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04095039 — N/A
Death Research Study Groups: Hi Arm, Lo Arm
Death Clinical Trial 2023: Hemodialysis Highlights & Side Effects. Trial Name: NCT04095039 — N/A
Hemodialysis (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04095039 — N/A
Death Patient Testimony for trial: Trial Name: NCT04095039 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are enrolled in this medical trial?

"A total of 4400 eligible patients must be enrolled in this pharmaceutical trial to complete the research. This initiative is being managed by Davita Clinical Research with sites located in Hastings, Illinois and Glencoe, North dakota."

Answered by AI

Are enrollment opportunities for this experiment still available?

"Affirmative. According to clinicaltrials.gov, this experiment is actively recruiting patients who meet the criteria. First posted on March 13th 2020 and last updated on November 10th 2022, it needs 4400 participants from 39 sites across the country."

Answered by AI

How many facilities are responsible for overseeing this clinical trial?

"This clinical research is recruiting from 39 different medical sites, including DaVita Historical Hastings in Hastings, DaVita Glencoe in Glencoe and DaVita East Valley in Apple Valley."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
What site did they apply to?
DaVita Cass Lake
DaVita Maplewood
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

tbh i will do anything so i can afforded college.
PatientReceived 2+ prior treatments
~162 spots leftby Mar 2025