NCT01612429|CompletedEarly Phase 1
Carbamylation in Renal Disease-modulation With Amino Acid Therapy
CarRAAT
Amino Acid Therapy to Modify Protein Carbamylation in End Stage Renal Disease
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CarRAAT
Amino Acid Therapy to Modify Protein Carbamylation in End Stage Renal Disease
Sponsor study identifier
Secondary identifiers
OTHER · NEIRB
interventional
23
1 country
1
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2015
Actual (reported)Study Completion
July 2015
Actual (reported)This is a pilot study to evaluate the effects of amino acid supplementation on the structure of certain proteins in the blood of dialysis patients. Patients with end stage renal disease (ESRD) usually have high levels of urea that may interact with blood proteins and change their structure by a process known as carbamylation. The investigators are interested in determining whether carbamylation is linked to adverse outcomes in dialysis patients and have hypothesized that supplementation with a balanced formulation of amino acids can reduce the amount of carbamylation that occurs. In this study, dialysis patients (n= up to 30) will receive intravenous supplementation with an FDA-approved amino acid solution (NephrAmine®, 5.4% amino acids) during regular dialysis sessions (3 times weekly for 6 weeks). During the 6 weeks of therapy and for 2 weeks of follow-up, blood will be drawn from patients' existing hemodialysis access ports (\~60 ml total per month) to measure levels of carbamylated albumin, amino acids, and standard laboratory values. Patients will be closely monitored for safety and tolerability of the amino acid therapy. For each treated subject, we will follow an additional individual that is not receiving treatment to serve as a control (no intervention).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 31, 2012
Actual (reported)June 5, 2012
Actual (reported)January 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 2015
Actual (reported)July 2015
Actual (reported)Change from baseline in plasma carbamylated albumin levels
Baseline and 6 weeks
Number of patients with adverse events
8 weeks
Up to 500 mL of 5.4% amino acid solution (NephrAmine) by intravenous infusion 3 x weekly for 6 weeks.
Single arm study in which dialysis patients will receive up to 500 mL of NephrAmine® (5.4% amino acids for injection; B. Braun Medical, Inc) containing 26.8 grams of essential amino acids at 125 mL/h during each dialysis session (3 times weekly for 6 weeks)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Kalim S, Ortiz G, Trottier CA, Deferio JJ, Karumanchi SA, Thadhani RI, Berg AH. The Effects of Parenteral Amino Acid Therapy on Protein Carbamylation in Maintenance Hemodialysis Patients. J Ren Nutr. 2015 Jul;25(4):388-92. doi: 10.1053/j.jrn.2015.01.019. Epub 2015 Mar 5.
Ravi Thadhani, MD, MPH
Massachusetts General Hospital
23 participants (actual enrollment reported by the registry).
First Submitted
May 31, 2012
First Posted
June 5, 2012
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
The Effects of Exercise in End-stage Renal Disease Patients Undergoing Hemodialysis
Contact the study team to confirm eligibility.
Primary Completion
July 2015
Actual (reported)Study Completion
July 2015
Actual (reported)Last Updated
November 10, 2016
Record last verified: 2016-11
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Source: ClinicalTrials.gov.
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