Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03812679 · ClinicalTrials.gov registry record · NA
Performance Evaluation of the AMIA APD Solution Generation System in Patients End Stage Renal Disease (ESRD)
A NA study, sponsored by Vantive Health.
- Terminated
- Registry status
- NA
- Development phase
- 22
- Enrollment target
NCT03812679: Clinical Trial NA study, sponsored by Vantive Health.
NCT03812679 is a NA study that was terminated before completion, run by Vantive Health. The registered enrollment target is 22 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03812679, a NA study, was terminated before completion, sponsored by Vantive Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
Study Summary
Peritoneal dialysis (PD) is a well-established treatment for renal failure including long-term management of end stage renal disease (ESRD) by continuous ambulatory peritoneal dialysis or automated peritoneal dialysis (APD). Complementary therapies offer longer term survival for patients with ESRD. However, none of them are devoid of side effects and today their limitations are better understood by the nephrologist. The AMIA APD Solution Generation System combines an updated AMIA APD Cycler with Sharesource Platform (previously cleared) with an in-home water system technology and leverages newly developed AMIA APD Concentrates. The AMIA APD Concentrates, after dilution by the AMIA APD Solution Generation System, are indicated for adult patients in acute or chronic renal failure when non-dialytic medical therapy is judged to be inadequate.
Primary Outcome
The dialysis solution generated by the simulated treatment will be sampled from the heater bag, compared to the specifications of Baxter's approved low calcium Dianeal PD solution. The following 9 test methods will be analyzed: pH at 25 C, Color, 5- (hydroxymethyl)furfural (5HMF), Dextrose hydrous Assay (1.5%, 2.5% or 4.25%), Sodium Lactate Assay, Sodium Assay, Chloride Assay, Magnesium Chloride Hexahydrate (MgCl2.6H2O) Assay, and Calcium Chloride Dihydrate (CaCl2.2H2O) Assay. Measurements were
Interventions
- DEVICE AMIA APD Solution Generation System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-12-20 |
| Est. Completion | 2020-02-19 |
| Phase | NA |
Why NCT03812679 stopped before completion
NCT03812679 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which AMIA APD Solution Generation System is the first listed.
NCT03812679 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03812679 about?
NCT03812679 is a clinical study titled "Performance Evaluation of the AMIA APD Solution Generation System in Patients End Stage Renal Disease (ESRD)". Peritoneal dialysis (PD) is a well-established treatment for renal failure including long-term management of end stage renal disease (ESRD) by continuous ambulatory peritoneal dialysis or automated peritoneal dialysis (APD). Complementary therapies offer longer term survival for patients with ESRD....
What is the current status of trial NCT03812679?
This trial is currently terminated. It is a NA study. The enrollment target is 22 participants. The study started on 2018-12-20. Estimated completion is 2020-02-19.
What interventions are being tested in trial NCT03812679?
The interventions under investigation include: AMIA APD Solution Generation System (DEVICE).
Who is sponsoring clinical trial NCT03812679?
This trial is sponsored by Vantive Health, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03812679's enrollment target sits among peer trials
22 1756th of 2000 higher than 239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02508038 · 22 participants · Phase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
- NCT03099356 · 22 participants · Phase 2
Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer
- NCT03676647 · 22 participants
Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules
- NCT04569591 · 22 participants · NA
DDAVP for Pituitary Adenoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI