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NCT01715883 · ClinicalTrials.gov registry record · Phase 2

Sodium Nitrite in Lung Transplant Patients to Minimize the Risk of Pulmonary Graft Dysfunction

A Phase 2 study, sponsored by Gladwin, Mark, MD.

Terminated
Registry status
Phase 2
Development phase
3
Enrollment target

NCT01715883: Clinical Trial Phase 2 study, sponsored by Gladwin, Mark, MD.

NCT01715883 is a Phase 2 study that was terminated before completion, run by Gladwin, Mark, MD. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01715883, a Phase 2 study, was terminated before completion, sponsored by Gladwin, Mark, MD.

TERMINATED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study Summary

This is a Phase 2 observational nonrandomized pilot investigation to evaluate the safety and efficacy of Sodium Nitrite administration for the reduction of Primary Graft Dysfunction (PGD) in patients undergoing lung transplant. The study will enroll 8 subjects, undergoing lung transplant at the University of Pittsburgh Medical Center (UPMC).

Primary Outcome

The safety of Sodium Nitrite administration will be assessed by methemoglobin levels during and 150 minutes after the nitrite infusion in the transplant recipient.

Interventions

  • DRUG Sodium Nitrite

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2011-10
Est. Completion 2017-05
Phase Phase 2
Gladwin, Mark, MD

11 total trials

Why NCT01715883 stopped before completion

NCT01715883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Sodium Nitrite is the first listed.

NCT01715883 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01715883 about?

NCT01715883 is a clinical study titled "Sodium Nitrite in Lung Transplant Patients to Minimize the Risk of Pulmonary Graft Dysfunction". This is a Phase 2 observational nonrandomized pilot investigation to evaluate the safety and efficacy of Sodium Nitrite administration for the reduction of Primary Graft Dysfunction (PGD) in patients undergoing lung transplant. The study will enroll 8 subjects, undergoing lung transplant at the Univ...

What is the current status of trial NCT01715883?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2011-10. Estimated completion is 2017-05.

What interventions are being tested in trial NCT01715883?

The interventions under investigation include: Sodium Nitrite (DRUG).

Who is sponsoring clinical trial NCT01715883?

This trial is sponsored by Gladwin, Mark, MD, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01715883's enrollment target sits among peer trials

3 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01715883, the US trial registry maintained by the National Library of Medicine. NCT01715883 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.