---
title: In Vivo Evaluation of the Nipro Elisio™ Dialyzer
nct_id: NCT01653808
overall_status: COMPLETED
phase: NA
sponsor: Nipro Europe N.V.
study_type: INTERVENTIONAL
primary_condition: Chronic Kidney Disease
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01653808.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01653808"
ct_last_update_post_date: 2012-09-14
last_seen_at: "2026-05-12T06:01:06.024Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# In Vivo Evaluation of the Nipro Elisio™ Dialyzer

**NCT ID:** [NCT01653808](https://clinicaltrials.gov/study/NCT01653808)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Nipro Europe N.V.
- **Conditions:** Chronic Kidney Disease
- **Start Date:** 2009-04
- **Completion Date:** 2012-09
- **CT.gov Last Update:** 2012-09-14

## Brief Summary

The purpose of this study is to compare the efficacy and biocompatibility of the Nipro Elisio 210H dialyzer between two dialysis modalities, conventional hemodialysis and on line hemodiafiltration.

## Detailed Description

Hemodiafiltration, a convective-based therapy combining both diffusive and convective transports appears as the treatment modality of choice for hemodialysis patients. Indeed, this innovative technique offers an effective dialysis modality removing spectrum of uremic solutes with an optimized biocompatibility of the extracorporeal circuit obtained with use of ultrapure dialysis and sterile substitution fluids. However, such therapy can not be proposed in all dialysis centers due to major drawbacks of this technique over conventional hemodialysis, the complexity of the system and its increased costs. Alternatively, enhancement of convective transport may now be achieved by use of innovative dialyzers allowing more internal filtration. This is the case of ELISIO™-H dialyzers which possess fibers of a greater internal length which potentially allow more internal filtration. Aim of the present study was therefore to evaluate efficacy and biocompatibility of internal filtration-enhanced hemodialysis using this dialyzer compared to hemodiafiltration, over a four-month period.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* CKD dialysis patients on treatment with three times a week HD for more than three months
* with a stable anticoagulation scheme
* with haemoglobin level \>10.5 g/dL
* with vascular access allowing a stable blood flow of 300 mL/min during treatment

Exclusion Criteria:

* patient already enrolled in another study
* pregnancy
* symptoms or signs of acute/chronic inflammatory or infectious diseases
```

## Arms

- **Elisio-210H with HD** (EXPERIMENTAL) — hemodialysis patients treated with conventional hemodialysis (HD) modality using Elisio-210H dialyzer
- **Elisio-210H with on line HDF** (ACTIVE_COMPARATOR) — hemodialysis patients treated with on line hemodiafiltration (HDF) modality using Elisio-210H dialyzer

## Interventions

- **Elisio-210H** (DEVICE) — comparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration
- **conventional hemodialysis** (PROCEDURE) — comparison of conventional hemodialysis with on line hemodiafiltration using Elisio-210H dialyzer
- **on line hemodiafiltration** (PROCEDURE) — comparison of on line hemodiafiltration with conventional hemodialysis using Elisio-210H dialyzer

## Primary Outcomes

- **pre-dialytic serum beta-2 microglobulin level** _(time frame: Month 1 (after one month))_

## Secondary Outcomes

- **reduction rate of low molecular weight solutes (urea and creatinine)** _(time frame: Month 0, 1, 2, 3, 4)_
- **dialysis dose (urea KT/V)** _(time frame: Month 0, 1, 2, 3, 4)_
- **instantaneous clearance of low molecular weight solutes (urea and creatinine)** _(time frame: Month 0, 1, 2, 3, 4)_
- **inflammatory markers (CRP, fibrinogen, orosomucoide)** _(time frame: month 0, 1, 2, 3, 4)_
- **inflammatory marker (interkeukin 6)** _(time frame: month 0, 4)_
- **nutritional status (albumin, transthyretin, homocysteine)** _(time frame: Month 0, 1, 2, 3, 4)_
- **endothelial progenitor cells** _(time frame: Month 0, 1, 2, 3, 4)_
- **inflammatory mononuclear cell activation** _(time frame: Month 0, 1, 2, 3, 4)_
- **kappa and lambda light chains** _(time frame: Month 0, 4)_
- **oxidative stress parameters (superoxide anion, AOPPs, AGEs)** _(time frame: Month 0, 4)_
- **coagulation factors (TFPI, PAI-1, tPA, von willebrand factor and factor VIII)** _(time frame: Month 0, 4)_
- **apoptosis markers (soluble FAS and FAS ligand)** _(time frame: Month 0, 4)_
- **bone markers (bone PAL, Cross Laps, TRAP5b)** _(time frame: Month 0, 4)_

## Locations (1)

- University Hospital Center, Montpellier, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university hospital center|montpellier||france` — added _(2026-05-12)_

---

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