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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 is a Early Phase 1 study that has completed, run by Emory University. The registered enrollment target is 24 participants.
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.
Interventions
- DRUG Losartan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-12 |
| Est. Completion | 2016-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01989078
The ClinicalTrials.gov registry entry for NCT01989078 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Losartan is the first listed.
NCT01989078 reports 0 study locations.
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.
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