Reduction of Oxalate and Inflammation by Hemodiafiltration vs. Hemodialysis

Summary

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.

Conditions

• Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

PROCEDURE

Hemodialysis

Hemodialysis \>/=4h

PROCEDURE

Hemodiafiltration

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

Sponsors & Collaborators

• Renal Research Institute

  collaborator OTHER

• University of Erlangen-Nürnberg Medical School

  lead OTHER

Principal Investigators

• Felix Knauf, MD · University Erlangen-Nuremberg, Germany

• Kai-Uwe Eckardt, MD · University Erlangen-Nuremberg, Germany

• Fred Finkelstein, MD · Medical Director of New Haven Home Dialysis

• Peter S Aronson, MD · Yale University New Haven, USA

• Chirag Parikh, MD · Yale University New Haven

• Mark A Perazella, MD · Yale University New Haven

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

CROSSOVER

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2016-09-30

Completion

2016-09-30

Countries

• Germany

Study Locations