EXtension of Tablo TrEatmeNt Duration Registry
XTEND
1 other identifier
observational
33
1 country
1
Brief Summary
Observational, retrospective and prospective, multicenter, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy \> 12 hours.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2021
CompletedFirst Submitted
Initial submission to the registry
May 26, 2021
CompletedFirst Posted
Study publicly available on registry
June 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedAugust 12, 2022
August 1, 2022
1 year
May 26, 2021
August 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment Success
Percentage of treatments achieving prescribed dialysis treatment time ≤ 10%
Up to 24 hours
Secondary Outcomes (1)
Tablo Cartridge Life
up to 24 hours
Study Arms (1)
Tablo Hemodialysis System
Hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy \> 12 hours on the Tablo Hemodialysis System
Interventions
Renal Replacement Therapy between 12\< to ≤ 24 hours.
Eligibility Criteria
Hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy \> 12 hours.
You may qualify if:
- Participant weighs ≥ 34kg.
- Participant is hospitalized and has dialysis dependent End-Stage Kidney Disease or Acute Kidney Injury and is prescribed renal replacement therapy \> 12 hours.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Outset Medicallead
Study Sites (1)
St. Mark's Hospital
Salt Lake City, Utah, 84124, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2021
First Posted
June 3, 2021
Study Start
May 25, 2021
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
August 12, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share
Only aggregated participant data is planned to be shared at this time.