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Reduction of Oxalate and Inflammation by Hemodiafiltration vs. Hemodialysis

NCT ID: NCT02684656

Last Updated: 2019-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-09-30

Brief Summary

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The health care burden of CKD is substantial and growing with 10-15% of the population affected in both developed and developing countries. It is well established that CKD is associated with systemic inflammation, which promotes cardiovascular disease and body wasting. However, causal therapies to treat systemic inflammation, and treat its adverse consequences remain sparse. As kidney function declines in all forms of CKD, oxalate levels increase in the plasma, leading to increased systemic exposure to oxalate and consequent tissue injury. Work from the investigators has shown that elevated plasma oxalate levels activate the NLRP3 inflammasome which in turn leads to the processing and release of cytokines. The investigators seek to test the hypothesis that oxalate contributes to the systemic inflammation observed in patients with end-stage renal disease (ESRD). The investigators plan to define the association between plasma oxalate levels and signs of systemic inflammation in patients on hemodialysis. In a second step the investigators will examine whether hemodiafiltration lowers plasma oxalate more efficiently than hemodialysis and reduces signs of systemic inflammation. Confirmation of the hypothesis may lead to the identification of oxalate as a novel therapeutic target for interventional trials aimed at reducing plasma oxalate in patients with ESRD.

Detailed Description

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The positive interaction between diffusive and convective flux has suggested that hemodiafiltration (HDF) has a higher oxalate extraction rate as compared with hemodialysis (HD). However, it has not been evaluated whether HDF can lower predialysis oxalate levels below the level of supersaturation. By using an intra-individual approach with the inclusion/exclusion criteria listed for the study, we plan to determine plasma oxalate and cytokine levels in 20 patients (10 on regular duration HD, 10 patients on extended duration HD) before dialysis. Subsequently, patients will be switched to HDF and plasma oxalate concentration and cytokines will be analyzed again two weeks following HDF treatment. Plasma oxalate (Pox) will be measured at beginning of treatment, mid, end and 2 hrs post treatment (to determine rebound) in order to provide oxalate kinetics on HD/HDF treatment. Cytokines will only be measured pre HD/HDF treatment to assess steady state inflammation.

Conditions

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Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

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Oxalate Inflammation Hemodiafiltration Hemodialysis Oxalate Blood Sample

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Hemodialysis

Intervention: Patients will be switch to hemodialysis and basal plasma oxalate levels as well as oxalate removal by hemodialysis will be determined after two weeks of treatment.

Group Type ACTIVE_COMPARATOR

Hemodialysis

Intervention Type PROCEDURE

Hemodialysis \>/=4h

Hemodiafiltration

Intervention: Patients will be switch back to hemodiafiltration and basal plasma oxalate levels as well as oxalate removal by hemodiafiltration will be determined after two weeks of treatment.

Group Type ACTIVE_COMPARATOR

Hemodiafiltration

Intervention Type PROCEDURE

Hemodiafiltration \>/=4h, \> 20l convection

Interventions

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Hemodialysis

Hemodialysis \>/=4h

Intervention Type PROCEDURE

Hemodiafiltration

Hemodiafiltration \>/=4h, \> 20l convection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Blood Flow ≥ 250 ml/min
* Dialysate Flow ≥ 500 ml/min
* Urinary Excretion \< 400 ml/24h
* Duration of Dialysis ≥ 4h
* On HDF/HD treatment for ≥ 4 weeks
* Extended HDF/HD for ≥ 4 weeks

Exclusion Criteria

* Recirculation (online measurement) \> 15%
* Single needle dialysis or single lumen catheter
* Substitution volume of \< 20l on HDF
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renal Research Institute

OTHER

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Felix Knauf, MD

Role: PRINCIPAL_INVESTIGATOR

University Erlangen-Nuremberg, Germany

Kai-Uwe Eckardt, MD

Role: PRINCIPAL_INVESTIGATOR

University Erlangen-Nuremberg, Germany

Fred Finkelstein, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Director of New Haven Home Dialysis

Peter S Aronson, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University New Haven, USA

Chirag Parikh, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University New Haven

Mark A Perazella, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University New Haven

Locations

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Nephrology Department, University Hospital Erlangen

Erlangen, Bavaria, Germany

Site Status

Countries

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Germany

References

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Hoppe B, Kemper MJ, Bokenkamp A, Portale AA, Cohn RA, Langman CB. Plasma calcium oxalate supersaturation in children with primary hyperoxaluria and end-stage renal failure. Kidney Int. 1999 Jul;56(1):268-74. doi: 10.1046/j.1523-1755.1999.00546.x.

Reference Type BACKGROUND
PMID: 10411702 (View on PubMed)

Knauf F, Asplin JR, Granja I, Schmidt IM, Moeckel GW, David RJ, Flavell RA, Aronson PS. NALP3-mediated inflammation is a principal cause of progressive renal failure in oxalate nephropathy. Kidney Int. 2013 Nov;84(5):895-901. doi: 10.1038/ki.2013.207. Epub 2013 Jun 5.

Reference Type BACKGROUND
PMID: 23739234 (View on PubMed)

Other Identifiers

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UErlangen-Nurnberg

Identifier Type: -

Identifier Source: org_study_id