Hemodialysis for Kidney Disease

Wake Forest Baptist Medical Center, Winston-Salem, NC
Kidney DiseaseHemodialysis - Other
All Sexes

Study Summary

This trial will test the feasibility of different regimens of hemodialysis, and the effects of those regimens on residual kidney function.

Eligible Conditions
  • End Stage Kidney Disease on Dialysis

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: up to 24 months

Day 90
Incidence rate of severe adverse events related to the intervention of stepped hemodialysis
up to 24 months
Assessment of Quality of Life- KDQOL-SF36 questionnaire
Change in residual kidney function
Events of hyperkalemia
Events of metabolic acidosis
Hospitalization Rate
Long-term change in residual kidney function
Protocol adherence rate
Recruitment rate
Solute clearance
Volume Management

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Conventional Hemodialysis Regimen
1 of 2
Hemodialysis and Pharmacologic Therapy
1 of 2

Active Control

Experimental Treatment

56 Total Participants · 2 Treatment Groups

Primary Treatment: Hemodialysis · No Placebo Group · Phase 3

Hemodialysis and Pharmacologic TherapyExperimental Group · 2 Interventions: Patiromer Oral Product, Hemodialysis · Intervention Types: Drug, Other
Conventional Hemodialysis Regimen
ActiveComparator Group · 1 Intervention: Hemodialysis · Intervention Types: Other
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,172 Previous Clinical Trials
1,057,966 Total Patients Enrolled
Mariana Murea, MDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
394 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your kidney function is so poor that your doctor has recommended starting dialysis treatment.

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
Wake Forest Baptist Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

Are we currently enrolling participants for this drug trial?

"This trial, which was originally posted on June 19th 2019 and last updated on June 22nd 2022, is actively searching for candidates." - Anonymous Online Contributor

Unverified Answer

What are the guidelines for this clinical trial's success?

"The aim of this experiment, which will last for a maximum of 24 months, is to study the Recruitment rate. Additionally, this trial will compare Monthly spKt/Vurea and stdKt/Vurea in the first quarter of hemodialysis between two treatment groups as a secondary outcome. Quality of Life- KDQOL-SF36 questionnaire will also be utilized as a metric to measure kidney disease burden, symptoms, and effects while Change in residual kidney function tracks renal urea clearance over time." - Anonymous Online Contributor

Unverified Answer

How many people are in this experiment?

"The listings on clinicaltrials.gov show that this study is still recruiting patients. This particular trial was first posted on June 19th, 2019 and was last updated June 22nd, 2020. They are looking for a total of 50 participants across 1 location." - Anonymous Online Contributor

Unverified Answer

Are there any similar studies to this one that have already been completed?

"4 clinical trials concerning hemodialysis are currently underway. Out of those 4, 2 have reached Phase 3. Although the majority of these trials take place in Durham, North Carolina, 25 total locations across the country are running similar studies." - Anonymous Online Contributor

Unverified Answer

Has Hemodialysis been cleared by the FDA?

"Hemodialysis received a score of 3 because, while this is only a Phase 3 trial, there is both some efficacy data and multiple rounds of safety data." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.