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NCT02472834 · ClinicalTrials.gov registry record · NA
Trial of Carbamylation in Renal Disease-Modulation With Amino Acid Therapy
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 54
- Enrollment target
NCT02472834: Completed NA study, sponsored by Massachusetts General Hospital.
NCT02472834 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 54 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02472834, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
Study Summary
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.
Interventions
- DIETARY_SUPPLEMENT Amino acid supplementation NephrAmine®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2016-02 |
| Est. Completion | 2020-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02472834
The ClinicalTrials.gov registry entry for NCT02472834 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Amino acid supplementation NephrAmine® is the first listed.
NCT02472834 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02472834 about?
NCT02472834 is a clinical study titled "Trial of Carbamylation in Renal Disease-Modulation With Amino Acid Therapy". 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...
What is the current status of trial NCT02472834?
This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2016-02. Estimated completion is 2020-12.
What interventions are being tested in trial NCT02472834?
The interventions under investigation include: Amino acid supplementation NephrAmine® (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02472834?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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