Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients
Public ClinicalTrials.gov record NCT03257410. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-Center, Prospective, Randomized, Controlled, Open-label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study evaluates the efficacy and safety of the Theranova 400 dialyzer compared with Elisio-17 H dialyzer in end stage renal disease patients receiving hemodialysis treatment. Efficacy will be determined by the removal of middle molecules (with different molecular size) from the blood compartment. Safety will be evaluated by maintaining pre-dialysis serum albumin levels and other safety events including laboratory tests and adverse events. Patients will undergo 3 dialysis sessions per week, for 24 weeks.
Study identification
- NCT ID
- NCT03257410
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 172 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 28, 2017
- Primary completion
- Oct 26, 2018
- Completion
- Oct 26, 2018
- Last update posted
- Jul 13, 2025
2017 – 2018
United States locations
- U.S. sites
- 20
- U.S. states
- 13
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| DaVita Corona | Corona | California | 92881 | — |
| DaVita Riverside | Riverside | California | 92501 | — |
| DaVita Inc, Greater Hartford Nephrology | Bloomfield | Connecticut | 06002 | — |
| DaVita Inc., Waterbury Dialysis | Middlebury | Connecticut | 06762 | — |
| Dialysis Center, Inc. Albany | Albany | Georgia | 31701 | — |
| Dialysis Center, Inc. Boston | Boston | Massachusetts | 02111 | — |
| Dialysis Center, Inc. Kidney Associates of Kansas City | Belton | Missouri | 64012 | — |
| Dialysis Center of Lincoln | Lincoln | Nebraska | 68510 | — |
| DaVita Five Star Dialysis Center | Las Vegas | Nevada | 89128 | — |
| DaVita Inc., South Las Vegas Dialysis | Las Vegas | Nevada | 89169 | — |
| Dialysis Center, Inc. North Brunswick | North Brunswick | New Jersey | 08902 | — |
| DaVita Inc., Bronx Dialysis Center | The Bronx | New York | 10461 | — |
| Dialysis Center, Inc. Philidelphia | Philadelphia | Pennsylvania | 19129 | — |
| Dialysis Center, Inc. Holston River Clinic | Knoxville | Tennessee | 37924 | — |
| DaVita Inc., Transmountain Dialysis | El Paso | Texas | 79902 | — |
| DaVita Inc., Medical Center Dialysis | Houston | Texas | 77004 | — |
| DaVita Renal Center of Lewisville | Lewisville | Texas | 75057 | — |
| DaVita Inc., Northwest Medical Center Dialysis | San Antonio | Texas | 78229 | — |
| DaVita Floyd Curl Dialysis | San Antonio | Texas | 78240 | — |
| DaVita Inc., Norfolk Dialysis | Chesapeake | Virginia | 23320 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03257410, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 13, 2025 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03257410 live on ClinicalTrials.gov.