Carbamylation in Renal Disease-modulation With Amino Acid Therapy

Completed · Early Phase 1

Conditions studied: End Stage Renal Failure on Dialysis

In brief

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).

Key facts

Study ID

NCT01612429

Run by

Massachusetts General Hospital

People needed

23

Starts

2013-01-01

Expected to finish

2015-07-01

Last updated by the study team

2016-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed of the investigational nature of the study and sign written informed consent
• Willing and able to adhere to all study-related procedures, including adherence to study medication regimen
• ≥18 years old
• On stable medical therapy in the last 30 days before the study entry, defined as no change, addition, or removal of medications
• Patients must satisfy the following criteria based on the initial screening laboratory values:
• Serum albumin ≥ 3.0 g/dL (30 g/L)
• Dialysis adequacy recorded as Kt/ V > 1.2
• Women of childbearing potential must be practicing barrier or oral contraception, for the duration of the study-related treatment, or be documented as surgically sterile or one year post-menopausal
• If female, be non-nursing, non-pregnant and have a negative pregnancy test within two weeks of starting study treatment
• On stable hemodialysis therapy for at least 90 days before the study entry, defined as receiving thrice weekly dialysis and carrying a diagnosis of ESRD
• Prescribed a dialysis treatment time of 4 hours per session

You may not qualify if…

• Taking any type of amino acid supplementation within the last 90 days
• Received parenteral nutrition within last 90 days
• History of allergy to any amino acid compound
• Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg during any of the previous 3 dialysis sessions (confirmed by repeat)
• Severe hepatic impairment
• Condition with prognosis <1 year at time of study entry
• Current active treatment in another investigational study or participation in another investigational study in the 1 month prior to screening
• Active malignancies or other serious concurrent or recent medical or psychiatric condition which, in the opinion of the Investigator, makes the patient unsuitable for participation in this study

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.