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NCT01989078 · ClinicalTrials.gov registry record · Early Phase 1
Losartan for Sickle Cell Kidney Disease
A Early Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 24
- Enrollment target
NCT01989078: Completed Early Phase 1 study, sponsored by Emory University.
NCT01989078 is a Early Phase 1 study that has completed, run by Emory University. The registered enrollment target is 24 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01989078, a Early Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Sickle cell nephropathy (SCN) is a progressive complication of sickle cell disease (SCD) that begins in childhood and results in renal (kidney) failure and early mortality in nearly 12% of adults with hemoglobin SS (HbSS). The potential for prevention and reversal of kidney damage in SCD is not known. Albuminuria is a commonly used biomarker of glomerular damage; however the correlations of albuminuria with specific measurements of glomerular function and pathophysiology have not been determined. The investigators hypothesize that in patients with persistent albuminuria despite treatment of SCD with hydroxyurea, losartan will reverse kidney dysfunction in early stage nephropathy and ameliorate progressive kidney dysfunction in more advanced nephropathy. The primary aim is to study the acute and longer-term effects of losartan (study drug) on specific glomerular functions in children and adults with SCD who have persistent albuminuria. Research glomerular function tests will be done at study entry (prior to taking losartan), 1 month, and 1 to 2 years after starting losartan therapy (participants may take losartan for up to 24 months). In addition, participants are seen each month in clinic and assessed by their regular clinical team. The second aim is to assess the correlation of changes in albuminuria after 1 month of losartan with changes in direct measurements of glomerular function at 12-24 months, thus determining if the magnitude of the initial decrease in albuminuria in response to losartan predicts sustained improvements in renal function.
Primary Outcome
The effects of losartan on the mean change in albumin/creatinine ratio (ACR) will be examined.
Interventions
- DRUG Losartan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-12 |
| Est. Completion | 2016-12 |
| Phase | Early Phase 1 |
What the finished NCT01989078 record still lists
NCT01989078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which Losartan is the first listed.
NCT01989078 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01989078 about?
NCT01989078 is a clinical study titled "Losartan for Sickle Cell Kidney Disease". Sickle cell nephropathy (SCN) is a progressive complication of sickle cell disease (SCD) that begins in childhood and results in renal (kidney) failure and early mortality in nearly 12% of adults with hemoglobin SS (HbSS). The potential for prevention and reversal of kidney damage in SCD is not know...
What is the current status of trial NCT01989078?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 24 participants. The study started on 2012-12. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01989078?
The interventions under investigation include: Losartan (DRUG).
Who is sponsoring clinical trial NCT01989078?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01989078's enrollment target sits among peer trials
24 1037th of 2000 higher than 914 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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