Trial of Carbamylation in Renal Disease-Modulation With Amino Acid Therapy
Completed · Not applicable
Conditions studied: End Stage Renal Failure on Dialysis
In brief
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. Evidence suggests that high levels of carbamylated proteins may be linked to adverse outcomes in dialysis patients. This is a randomized, open-label study to evaluate the effects of amino acid supplementation on levels of carbamylated proteins in ESRD patients. Secondary objectives will be to determine whether this intervention can modify intermediate markers of inflammation, cardiac stress, and erythropoietin responsiveness in this population. Sixty ESRD patients on dialysis will be randomized into two groups of 30 patients each. Group 1 will receive intravenous supplementation with an FDA-approved amino acid solution (250 mL of NephrAmine®, 5.4% amino acids) during regular dialysis sessions (3 times weekly for 8 weeks); Group 2 will be treated according to standard-of-care (no amino acid supplementation). During the 8 weeks of therapy and for 4 weeks of follow-up, blood will be drawn from patients' existing hemodialysis access ports (\~20 mL once per month) to measure levels of carbamylated albumin, amino acids, selected biomarkers, and standard laboratory values. Patients randomized to Group 1 will have fluid volume equivalent to the amino acid therapy removed by ultra-filtration to avoid net fluid gain. All patients will be monitored for safety (adverse events) and for changes in hemodynamics and dialysis prescription.
Key facts
- Study ID
- NCT02472834
- Run by
- Massachusetts General Hospital
- People needed
- 54
- Starts
- 2016-02-01
- Expected to finish
- 2020-12-01
- Last updated by the study team
- 2021-02-24
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
- Carbamylated albumin (C-Alb) > 7.7 mmol/mol
- 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
- HIV positive
- Condition with prognosis <1 year at time of study entry
- Body Mass Index (BMI) <18 or >30
- 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
- Presence of asthma
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Fresenius Medical Centers (local affilliates) — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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