Acid-Base Composition With Use of hemoDialysates

NCT02334267 | Completed Results DMC FDA Device

• 1 other identifier: ABChD
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single center, single blind (patient and laboratory), randomized, cross-over, two week investigation of intradialytic acid-base kinetics and physiology associated with use of two commercial acid dialysate concentrates in prevalent hemodialysis patients.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (4)

• Peridialytic Arterialized Blood Bicarbonate Concentrations

  Quantification of Peridialytic Arterialized Blood Bicarbonate Concentrations

  Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysis

• Peridialytic Venous Blood Bicarbonate Concentrations

  Quantification of Peridialytic Venous Blood Bicarbonate Concentrations

  25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis

• Peridialytic Arterialized Blood Acetate Concentrations

  Quantification of Peridialytic Arterialized Blood Acetate Concentrations

  Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysis

• Peridialytic Venous Blood Acetate Concentrations

  Quantification of Peridialytic Venous Blood Acetate Concentrations

  25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis

Study Arms (2)

Group 1: GranuFlo

ACTIVE COMPARATOR

Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of NaturaLyte for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments.

Device: Group 1: GranuFlo

Group 2: NaturaLyte

ACTIVE COMPARATOR

Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of GranuFlo for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments.

Device: Group 2: NaturaLyte

Interventions

Group 1: GranuFlo DEVICE

Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using NaturaLyte, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments.

Also known as: GranuFlo 45X

Group 1: GranuFlo

Group 2: NaturaLyte DEVICE

Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using GranuFlo, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments.

Also known as: NaturaLyte 45X

Group 2: NaturaLyte

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects eligible to be entered into this study will meet all of the following criteria:
• Adult female or male patients; age ≥18 years.
• End stage renal disease (ESRD) patients treated for \>90 days with the modality of maintenance hemodialysis and on a stable dialysis prescription for the prior month.
• Patients utilizing a hemodialysis vascular access of a functioning arteriovenous fistula (AVF) or graft (AVG) during the prior month. The patient's AVF/AVG must be considered in stable functioning condition and not be expected to require any surgical revision/intervention during participation in the trial.
• Patients with an average spKt/V of ≥1.2 during 30 days prior to screening as determined by historic monthly laboratory adequacy measurements; for patients with only one available spKt/V an average will not be performed. (Note: spKt/V should not be captured from dialysis machine adequacy measurements.)
• Screening hemoglobin level of ≥9 g/dL, and investigator considers hemoglobin levels to have been clinically stable for at least 30 days.
• A sodium bicarbonate basic dialysate prescription that has not had any changes for 30 days prior to randomization, and is anticipated to be unchanged during study participation as determined by the investigator.
• Unchanged heparin dosing regimen for the past 30 days prior to randomization and anticipated unchanged heparin dosing during participation in this clinical trial.
• No changes two weeks prior to randomization or anticipated changes throughout the study in any phosphate binders, calcium supplements, anticoagulant therapies that are not used for hemodialysis treatment (e.g. warfarin, dabigatran, apixaban, rivaroxaban and acetylsalicylic acid (ASA)), non-dialysate sodium bicarbonate and/or citrate based concomitant medications.
• If treated with systemic glucocorticoid/corticosteroid medications, no dose changes in the previous two months before randomization, or anticipated dose changes throughout the study duration; the dosing regimen should be consistent with maintenance therapy (i.e. not for an acute or active uncontrolled disease) as determined by the investigator. (Note: this criteria does not pertain to inhaled and/or topical glucocorticoid/corticosteroid therapies)
• During the two weeks prior to screening, an average of no more than 3.5 kg in pre-dialysis weight gain. In the event greater than 3.5 kg is noted, the investigator will discuss the specific medical history with the Medical Monitor prior to enrollment.
• Willing to comply with all study procedures and be available for the duration of the study.

You may not qualify if:

• Patients that meet any of the following criteria will be ineligible for this study:
• Patients unable to provide a signed and dated informed consent for this clinical research study.
• Pregnant or lactating female patients.
• Females of reproductive potential who do not agree to use a highly effective method of contraception, as determined by the investigator.
• Missed a scheduled outpatient dialysis treatment within two weeks prior to screening or anticipated to not attend any prescribed hemodialysis treatments during participation in the study.
• Screening or historic laboratory values of aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) levels ≥ 2 times the upper limit of normal. These blood laboratory tests must have been performed within 30 days prior to screening or prior to randomization.
• A screening or historic laboratory value of total bilirubin \>1.9 mg/dL that was collected within 30 days prior to screening or obtained before randomization.
• Uncontrolled clinically significant blood pressure as determined by the investigator within 30 days prior to screening.
• Active or recent bleeding disorder within the past 30 days.
• Screening or historic platelet count \<100,000 platelets per microliter (mcL) that was collected within 30 days prior to screening or before randomization.
• Chronic supplemental oxygen use within 30 days prior to randomization.
• Current active and significant chronic obstructive pulmonary disease (COPD) as determined by the investigator.
• Active malignancy or a malignancy within the past five years, with exceptions for basal and squamous cell carcinoma.
• Active and clinically uncontrolled autoimmune disease as determined by the investigator. Subjects with controlled autoimmune diseases must be considered to be clinically stable in the opinion of the investigator (e.g. subjects with systemic lupus erythematosus (SLE) and no recent flares are not excluded). The investigator will consult with the referring physician if it is necessary to confirm the stability of an autoimmune disease.
• Diagnosed with human immunodeficiency virus (HIV).

Sponsors & Collaborators

• Fresenius Medical Care North America: lead

Study Sites (1)

Volunteer Research Group and New Orleans Center for Clinical Research

Knoxville, Tennessee, 37920, United States

Location

Related Publications (1)

• Smith WB, Gibson S, Newman GE, Hendon KS, Askelson M, Zhao J, Hantash J, Flanagan B, Larkin JW, Usvyat LA, Thadhani RI, Maddux FW. The dynamics of the metabolism of acetate and bicarbonate associated with use of hemodialysates in the ABChD trial: a phase IV, prospective, single center, single blind, randomized, cross-over, two week investigation. BMC Nephrol. 2017 Aug 29;18(1):273. doi: 10.1186/s12882-017-0683-6.

  PMID: 28851317 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Brigid Flanagan, MS, RN, CCRC
• Organization: Frenova Renal Research

Brigid.Flanagan@frenovarenalresearch.com

781-699-2970

Study Officials

• William B Smith, MD

  Volunteer Research Group and New Orleans Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: January 8, 2015
• Study Start: November 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 9, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)