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NCT02046395 · ClinicalTrials.gov registry record · Phase 4

Effect of Renin-angiotensin-system Blockade on Urinary Free Light Chains in Patients With Type 2 Diabetes Mellitus

A Phase 4 study, sponsored by Tulane University School of Medicine.

Completed
Registry status
Phase 4
Development phase
28
Enrollment target

NCT02046395: Completed Phase 4 study, sponsored by Tulane University School of Medicine.

NCT02046395 is a Phase 4 study that has completed, run by Tulane University School of Medicine. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02046395, a Phase 4 study, has completed, sponsored by Tulane University School of Medicine.

COMPLETED
Registry status
Phase 4
Development phase
28 participants
Enrollment target

Study Summary

The purpose of this study is to study the effect of blocking the renin angiotensin system on urinary free light chain excretion as compared to urine microalbumin creatinine ratio in subjects with type 2 diabetes. The long term goal is to assess urinary free-light chains as a biomarker of earlier detection of kidney function impairment in subjects with diabetes mellitus.

Primary Outcome

Kidney function will be assessed throughout the study to assess changes in function prior to the washout of ACE/ARB medication and reintroduction of the ACE/ARB medication.

Interventions

  • DRUG amlodipine, hydralazine, terazosin or hydrochlorothiazide

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2012-01
Est. Completion 2019-12
Phase Phase 4

What the finished NCT02046395 record still lists

NCT02046395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which amlodipine, hydralazine, terazosin or hydrochlorothiazide is the first listed.

NCT02046395 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02046395 about?

NCT02046395 is a clinical study titled "Effect of Renin-angiotensin-system Blockade on Urinary Free Light Chains in Patients With Type 2 Diabetes Mellitus". The purpose of this study is to study the effect of blocking the renin angiotensin system on urinary free light chain excretion as compared to urine microalbumin creatinine ratio in subjects with type 2 diabetes. The long term goal is to assess urinary free-light chains as a biomarker of earlier det...

What is the current status of trial NCT02046395?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2012-01. Estimated completion is 2019-12.

What interventions are being tested in trial NCT02046395?

The interventions under investigation include: amlodipine, hydralazine, terazosin or hydrochlorothiazide (DRUG).

Who is sponsoring clinical trial NCT02046395?

This trial is sponsored by Tulane University School of Medicine, which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02046395's enrollment target sits among peer trials

28 1635th of 2000 higher than 350 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02046395, the US trial registry maintained by the National Library of Medicine. NCT02046395 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.