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Reduction of Oxalate and Inflammation by Hemodiafiltration vs. Hemodialysis

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ClinicalTrials.gov Identifier: NCT02684656
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : December 24, 2019
Sponsor:
Collaborator:
Renal Research Institute
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Tracking Information
First Submitted Date  ICMJE February 9, 2016
First Posted Date  ICMJE February 18, 2016
Last Update Posted Date December 24, 2019
Actual Study Start Date  ICMJE February 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
Plasma oxalate [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
Cytokines measured by multiplex analysis [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reduction of Oxalate and Inflammation by Hemodiafiltration vs. Hemodialysis
Official Title  ICMJE Pilot Study of Lowering Plasma Oxalate With Hemodiafiltration to Reduce Systemic Inflammation in Patients With End-Stage Renal Disease (ESRD)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Chronic Kidney Disease Requiring Chronic Dialysis
Intervention  ICMJE
  • Procedure: Hemodialysis
    Hemodialysis >/=4h
  • Procedure: Hemodiafiltration
    Hemodiafiltration >/=4h, > 20l convection
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Hemodialysis
  • 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.
    Intervention: Procedure: Hemodiafiltration
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2019)
14
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2016)
20
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02684656
Other Study ID Numbers  ICMJE UErlangen-Nurnberg
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Erlangen-Nürnberg Medical School
Study Sponsor  ICMJE University of Erlangen-Nürnberg Medical School
Collaborators  ICMJE Renal Research Institute
Investigators  ICMJE
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
PRS Account University of Erlangen-Nürnberg Medical School
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP