Altering Bicarbonate Delivery During Hemodialysis to Affect Filtration of Indoxyl Sulfate

NCT02639624 | Withdrawn FDA Drug

• 1 other identifier: 14-01343
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non randomized crossover trial investigating whether changing the pattern of bicarbonate administration during hemodialysis will result in the more efficient filtration of highly protein bound solutes. The experimental group will be dialyzed with low bicarbonate dialysate for the first half of dialysis then switched over to normal bicarbonate dialysate for the second half. The control group will be dialyzed entirely with normal bicarbonate dialysate. The two groups will switch one week late and patients will serve as their own matched controls for a completely standard dialysis and one that is split into two halves with different bicarbonate concentrations.

Conditions

Renal Dialysis; Hemodialysis

Keywords

hemodialysis; kidney; dialysis

Outcome Measures

Primary Outcomes (1)

• Change in the amount of Indoxyl Sulfate level in the first half of dialysis as compared to controls

  1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes

Secondary Outcomes (1)

• Change in pH

  1 Minute, 75 Minutes, 105 Minutes, 180 Minutes, 210 Minutes

Study Arms (2)

Low bicarbonate dialysate First

EXPERIMENTAL

Dialysis with low bicarbonate dialysate (expected normal for an adult \~24 mEq) for the first half of dialysis then switched over to normal bicarbonate dialysate for the second half.

Drug: Low bicarbonate dialysate First; Drug: Normal bicarbonate dialysate

Normal bicarbonate dialysate First

ACTIVE COMPARATOR

Dialysis with normal (37 mEq) for the first half of dialysis then switched over to low bicarbonate dialysate

Drug: Normal bicarbonate dialysate First; Drug: Low bicarbonate dialysate

Interventions

Low bicarbonate dialysate First DRUG

Low bicarbonate dialysate First

Normal bicarbonate dialysate First DRUG

Normal bicarbonate dialysate First

Normal bicarbonate dialysate DRUG

Low bicarbonate dialysate First

Low bicarbonate dialysate DRUG

Normal bicarbonate dialysate First

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Stable Dialysis for at least 6 months

You may not qualify if:

• Patients with serum potassium concentration below 4.0 mEq/L on previous monthly lab test or corrected serum calcium below 8.5 mEq/L
• Hospitalization within the past 12 months
• Adults unable to consent
• Children
• Pregnant women
• Prisoners

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Study Officials

• Jerome Lowenstein

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 24, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 31, 2017

Record last verified: 2017-07

Locations

US (1)