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Reduction of Oxalate and Inflammation by Hemodiafiltration vs. Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02684656
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : December 24, 2019
Renal Research Institute
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Requiring Chronic Dialysis Procedure: Hemodialysis Procedure: Hemodiafiltration Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of Lowering Plasma Oxalate With Hemodiafiltration to Reduce Systemic Inflammation in Patients With End-Stage Renal Disease (ESRD)
Actual Study Start Date : February 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 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.
Procedure: Hemodialysis
Hemodialysis >/=4h

Active Comparator: 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.
Procedure: Hemodiafiltration
Hemodiafiltration >/=4h, > 20l convection

Primary Outcome Measures :
  1. Plasma oxalate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Cytokines measured by multiplex analysis [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02684656

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Nephrology Department, University Hospital Erlangen
Erlangen, Bavaria, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Renal Research Institute
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Principal Investigator: Felix Knauf, MD University Erlangen-Nuremberg, Germany
Principal Investigator: Kai-Uwe Eckardt, MD University Erlangen-Nuremberg, Germany
Principal Investigator: Fred Finkelstein, MD Medical Director of New Haven Home Dialysis
Principal Investigator: Peter S Aronson, MD Yale University New Haven, USA
Principal Investigator: Chirag Parikh, MD Yale University New Haven
Principal Investigator: Mark A Perazella, MD Yale University New Haven
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Responsible Party: University of Erlangen-Nürnberg Medical School Identifier: NCT02684656    
Other Study ID Numbers: UErlangen-Nurnberg
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Erlangen-Nürnberg Medical School:
Oxalate Blood Sample
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Pathologic Processes
Urologic Diseases
Renal Insufficiency