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NCT01612429 · ClinicalTrials.gov registry record · Early Phase 1
Carbamylation in Renal Disease-modulation With Amino Acid Therapy
A Early Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 23
- Enrollment target
NCT01612429: Completed Early Phase 1 study, sponsored by Massachusetts General Hospital.
NCT01612429 is a Early Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 23 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01612429, a Early Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
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).
Interventions
- DIETARY_SUPPLEMENT Amino acid supplementation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-07 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01612429
The ClinicalTrials.gov registry entry for NCT01612429 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 23 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 is the first listed.
NCT01612429 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01612429 about?
NCT01612429 is a clinical study titled "Carbamylation in Renal Disease-modulation With Amino Acid Therapy". 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 proc...
What is the current status of trial NCT01612429?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 23 participants. The study started on 2013-01. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01612429?
The interventions under investigation include: Amino acid supplementation (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01612429?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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