Who is sponsoring NCT02561247?

NCT02561247 is sponsored by Vantive Health LLC.

What drugs are being tested in NCT02561247?

Interventions in NCT02561247: Prismaflex HF20 CRRT Filter, Prismaflex® System 7.10 and 7.20.

What condition does NCT02561247 study?

NCT02561247 studies Acute Kidney Injury in Pediatric Patients.

Is NCT02561247 still recruiting?

NCT02561247 is currently terminated. Last updated 14 July 2025.

Are results published for NCT02561247?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-07-14 · How we verify

NCT02561247

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Prismaflex HF20 Set and Prismaflex® System 7.10/7.20 for Acute Continuous Renal Replacement Therapy (CRRT) in Children

Terminated NA Results posted Last updated 14 July 2025

What this trial tests

NA trial testing Prismaflex HF20 CRRT Filter in Acute Kidney Injury in Pediatric Patients in 23 participants. Terminated before completion.

Timeline

10 November 2015

Primary endpoint
6 April 2018

6 April 2018

Quick facts

Lead sponsor	Vantive Health LLC
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	10 November 2015
Primary completion	6 April 2018
Estimated completion	6 April 2018
Sites	6 locations across United States

Drugs / interventions tested

Prismaflex HF20 CRRT Filter
Prismaflex® System 7.10 and 7.20

Conditions studied

Acute Kidney Injury in Pediatric Patients — all drugs for Acute Kidney Injury in Pediatric Patients →

Sponsor

Vantive Health LLC — full company profile →

Who can join

Eligibility, any sex, with Acute Kidney Injury in Pediatric Patients. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change From Baseline in BUN (mg/dL) at 24 Hours Following Initiation of CRRT Primary · 24 hours from CRRT initiation

Blood Urea Nitrogen (BUN)

Group	Value	95% CI
Prismaflex HF20 CRRT	-58.118	± 20.0848

Percent Change From Baseline in Creatinine (Umol/L) at 24 Hours Following Initiation of CRRT Secondary · 24 hours from CRRT initiation

Group	Value	95% CI
Prismaflex HF20 CRRT	-45.687	± 19.8848

Percent Change From Baseline in Bicarbonate (mmol/L) at 24 Hours Following Initiation of CRRT Secondary · 24 hours from CRRT initiation

Group	Value	95% CI
Prismaflex HF20 CRRT	38.287	± 29.6885

HF20 Set Filter Survival Time Secondary · Up to 72 Hours after Initiation

Filters that were replaced any time CRRT was stopped for reasons other than the failure to mediate the two alarms specified were censored at their current duration of usage (filter clotted and TMP excessive). Only filters that were replaced due to the two alarms were considered events for this survival analysis. A total of 34 filters were used in the study and 22 filters were censored, leaving data from only 12 filters to complete the survival estimate. Due to the small amount of filter data available, only the 25th percentile survival estimate was used since the 50th and 75th percentiles were

25th Percentile

Group	Value	95% CI
Prismaflex HF20 CRRT	11.79	5.07 – 68.09

50th Percentile

Group	Value	95% CI
Prismaflex HF20 CRRT	NA	18.65 – NA

75th Percentile

Group	Value	95% CI
Prismaflex HF20 CRRT	NA	NA – NA

Number of Participants Experiencing at Least One Prismaflex Alarms Related to Fluid Balance and Extracorpeal Life Secondary · Up to 72 hours from CRRT initiation

The end of the extracorporeal circuit life will be defined by the occurrence of one or both of the following Prismaflex ® System alarms, after which CRRT will be terminated and the extracorporeal circuit replaced: * Warning: Filter is Clotted, and/or * Caution: TMP (Trans Membrane Pressure) Excessive Alarms from Prismaflex ® System 7.10 related to fluid balance will be noted and recorded for the following alarms: * Caution: Flow Problem * Caution: Gain Limit Reached * Caution: Loss Limit Reached

Alarm: Warning Filter Clotted

Group	Value	95% CI
Prismaflex HF20 CRRT	7

Alarm: Caution TMP Excessive

Group	Value	95% CI
Prismaflex HF20 CRRT	1

Alarm: Caution Flow Problem

Group	Value	95% CI
Prismaflex HF20 CRRT	13

Alarm: Warning Loss Limit Reached

Group	Value	95% CI
Prismaflex HF20 CRRT	0

Alarm: Warning Gain Limit Reached

Group	Value	95% CI
Prismaflex HF20 CRRT	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 24 hours prior to CRRT (Screening) through HF20 CRRT End (72 hours), for a total of up to 96 hours. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Prismaflex HF20 CRRT

Serious: 5/23 (22%)

Deaths: 2/23

Serious adverse events (8 terms)

Reaction	System	Prismaflex HF20 CRRT
Cardiac Arrest	Cardiac disorders	—
Right Ventricular Failure	Cardiac disorders	—
Hypercalcaemia	Metabolism and nutrition disorders	—
Intraventricular Haemorrhage	Nervous system disorders	—
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	—
Pulmonary Haemorrhage	Respiratory, thoracic and mediastinal disorders	—
Pulmonary Hypertensive Crisis	Respiratory, thoracic and mediastinal disorders	—
Peripheral Ischaemia	Vascular disorders	—

Other adverse events (15 terms — click to expand)

Reaction	System	Prismaflex HF20 CRRT
HYPOKALAEMIA	Metabolism and nutrition disorders	—
HYPOTHERMIA	General disorders	—
HYPERCALCAEMIA	Metabolism and nutrition disorders	—
HYPERTENSION	Vascular disorders	—
BRADYCARDIA	Cardiac disorders	—
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	—
HYPOTENSION	Vascular disorders	—
THROMBOCYTOPENIA	Blood and lymphatic system disorders	—
HEPATIC FAILURE	Hepatobiliary disorders	—
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	—
CITRATE TOXICITY	Injury, poisoning and procedural complications	—
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	—
LACTIC ACIDOSIS	Metabolism and nutrition disorders	—
AGITATION	Psychiatric disorders	—
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Cardiac Arrest, Right Ventricular Failure, Hypercalcaemia, Intraventricular Haemorrhage, Pleural Effusion, Pulmonary Haemorrhage, Pulmonary Hypertensive Crisis, Peripheral Ischaemia.

Data from ClinicalTrials.gov NCT02561247 adverse events section.

Sponsor's own description

The primary objective of this study is to evaluate the efficacy of the Gambro Prismaflex® HF20 Set based on testing the hypothesis that it delivers sufficient renal replacement therapy to effectively treat acute kidney injury (AKI) in pediatric patients by reducing blood urea nitrogen (BUN).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pediatric Acute Kidney Injury-The Time for Nihilism Is Over.
Goldstein SL. · · 2020 · cited 6× · PMID 32083043 · DOI 10.3389/fped.2020.00016

Verify or expand the search:

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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02561247 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 14 July 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/NCT02561247.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing