Atherosclerotic Renal Artery Stenosis Clinical Trial
• Background: Since evidence show that renal-artery stenting did not confer a significant
benefit with respect to the prevention of clinical events when added to comprehensive,
multifactorial medical therapy in people with atherosclerotic renal-artery stenosis[1], the
aim of our study was to confirm Fu-zheng-qu-zhuo (FZQZc) oral liquid, a herbal medicine,
combined with optimal medical therapy of internal medicine (OMT), including anti-platelet
therapy and other protocol-driven medical therapies to control blood pressure and glucose
and lipid levels in accordance with guidelines,resulted in greater renal function protection
in patients with atherosclerotic renal artery stenosis ( ARAS) compared with OMT alone.
Methods : A randomized, placebo-controlled, single centre clinical design. Sixty patients
with diagnosed atherosclerotic renal artery stenosis and had chronic kidney disease stage 3
will be recruited, and will be randomized into two groups in a 1:1 ratio ( FZQZ and placebo
Group, 30 respectively). FZQZ Oral liquid or placebo 20 ml every time, three times a day for
different groups, meanwhile, all participants in both treatment groups received OMT, 6
months therapeutic period. Serum creatinine, estimated glomerular filtration rate(eGFR),
urine protein, and cardiovascular and renal events (a composite end point of death from
cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for
congestive heart failure, progressive renal insufficiency, or the need for renal-replacement
therapy) will be compared between the Groups as the outcome.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01840540 -
MSC for Occlusive Disease of the Kidney
|
Phase 1 |