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NCT03547336
Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis Comparing the Theranova Dialyzer to Hemodiafiltration
NA trial testing Theranova 400 Dialyzer in End Stage Renal Disease in 212 participants. Completed in 4 January 2020.
4 January 2020
Quick facts
| Lead sponsor | Vantive Health LLC |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 212 |
| Start date | 29 June 2018 |
| Primary completion | 4 January 2020 |
| Estimated completion | 4 January 2020 |
| Sites | 8 locations across China |
Drugs / interventions tested
- Theranova 400 Dialyzer
- FX800 Dialyzer
Conditions studied
- End Stage Renal Disease — all drugs for End Stage Renal Disease →
Sponsor
Vantive Health LLC — full company profile →
Who can join
18 and older, any sex, with End Stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In China, the estimated prevalence of patients with ESRD receiving PD or maintenance HD increased from 51.7 per million population (pmp) at the end of 2007 to 79.1 pmp at the end of 2008. Theranova 400 is designed to deliver the performance of hemodiafiltration (HDF) using standard hemodialysis (HD) equipment and treatment mode, including HD machines, disposables, blood and dialysate flows, length of treatment and frequency of treatment. Theranova 400 utilizes a Medium Cut-Off (MCO) membrane with extended permeability for middle solutes to closely modulate the removal function of the kidney without the complexity of HDF. The primary objective of the study is to demonstrate non-inferiority of the Theranova Dialyzer in hemodialysis (HD) mode compared to hemodiafiltration (HDF), using FX 800 in HDF mode. Comparison of the study arms over time will be used to support the safety of Theranova 400 by demonstrating stable serum albumin levels, as well as support the dialyzer's efficacy to significantly remove serum middle molecules.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03547336
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Theranova 400 Dialyzer
Trials testing the same drug.
- NCT05309291 — Theranova Randomized, Controlled, Trial (RCT) in China · NA · completed
- NCT03547323 — Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis to Determine Non-inferiority of the Theranova Dialyzer · NA · completed
Other recruiting trials for End Stage Renal Disease
Currently open trials in the same condition.
- NCT06257134 — Impact on Quality of Life of Symptoms Routine E-monitoring Among Dialysis Patients. · NA · recruiting
- NCT06310161 — Light Therapy in End Stage Kidney Disease · NA · recruiting
- NCT07360938 — Drug Interaction Potential of Pro-Inflammatory Conditions · recruiting
- NCT06422871 — PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis · recruiting
- NCT06861816 — Ventilatory Functions and Physical Intolerance in ESRD Adolescents: Response to Program of Walking With Dogs · NA · recruiting
Other Vantive Health LLC trials
Trials by the same sponsor.
- NCT07326215 — A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+ · NA · recruiting
- NCT06633029 — Retrospective Analysis of Prismaflex HF20 Set Versus ppCRRT Registry · completed
- NCT06983509 — Registry of Pre-mixed Solutions in Critically Ill Patients on the Continuous Renal Replacement Therapy · completed
- NCT06492031 — Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients · completed
- NCT05888376 — A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03547336 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vantive Health LLC
- Last refreshed: 13 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03547336.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing