Acid-Base Composition With Use of Hemodialysates

End Stage Renal Disease Clinical Trial

— ABChD  

Official title:

Acid-Base Composition With Use of Hemodialysates

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02334267
• Other study ID #: ABChD
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 11, 2014
• Last updated: April 24, 2015
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: Fresenius Medical Care North America
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a physiology study of two commercially available dialysate acid concentrates. It is a prospective, single center single blind, cross-over, two week investigation of intradialytic acid-base kinetics and physiology using two commercially available acetate hemodialysate compositions in prevalent hemodialysis patients.

Description:

Approximately 10-20 prevalent hemodialysis patients will be recruited. Subjects will receive one weekly hemodialysis treatment using each of the two acetate acid dialysates of NaturaLyte and GranuFlo.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects eligible to be entered into this study will meet all of the following criteria:

1. Adult female or male patients; age =18 years.

2. End stage renal disease (ESRD) patients treated for >90 days with the modality of maintenance hemodialysis receiving treatments three times per week for the prior month.

3. 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.

4. 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.)

5. 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.

6. Unchanged heparin dosing regimen for the past 30 days prior to randomization and anticipated unchanged heparin dosing during participation in this clinical trial.

7. 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.

8. No significant change in predialysis weight (i.e. >2kg in change) within two weeks prior to screening.

9. Willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

1. Patients unable to provide a signed and dated informed consent for this clinical research study.

2. Pregnant or lactating female patients.

3. Females of reproductive potential who do not agree to use a highly effective method of contraception, as determined by the investigator.

4. Missed or anticipated to not attend any prescribed hemodialysis treatments within two weeks prior to screening and during participation in the study.

5. 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.

6. 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.

7. Uncontrolled anemia as defined as a screening or historic hemoglobin value of <9 g/dL that was collected within 30 days before screening or prior to randomization.

8. Uncontrolled clinically significant blood pressure as determined by the investigator within 30 days prior to screening.

9. Active or recent bleeding disorder within the past 30 days.

10. Screening or historic platelet count <100,000 platelets per microliter (mcL) that was collected within 30 days prior to screening or before randomization.

11. Chronic supplemental oxygen use within 30 days prior to randomization.

12. Current active and significant chronic obstructive pulmonary disease (COPD) as determined by the investigator.

13. Currently treated or recently treated in the past 30 days with glucocorticoids/corticosteroids, with exception of inhaled and/or topical glucocorticoid/corticosteroid therapies.

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• GranuFlow
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: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.
• NaturaLyte
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: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.

Locations

Country	Name	City	State
United States	Volunteer Research Group and New Orleans Center for Clinical Research	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of serum bicarbonate and acetate levels	Serum and dialysate samples, time points: immediately prior to, and 25, 30, 60, 90,120,150,180 and 210 minute timepoints, and 240 min. immediately post dialysis.	up to 240 minute	No
Secondary	Quantification of serum bicarbonate changes using NaturaLyte and GranuFlo	serum and dialysate samples, time points: immediately prior to, and 25, 30, 60, 90,120,150,180 and 210 minute timepoints, and 240 immediately post dialysis. Time will not exceed 240 minutes.	up to 240 minute	No
Secondary	Quantification of blood bicarbonate levels in comparison to blood acetate levels	serum and dialysate samples, time points: immediately prior to, and 25, 30, 60, 90,120,150,180 and 210 minute timepoints, and 240 immediately post dialysis. Time will not exceed 240 minutes.	up to 240 minute	No