| Trial ID: | L1431 |
| Source ID: | NCT01023373
|
| Associated Drug: |
Medical Treatment
|
| Title: |
Revascularization of Renal Artery Stenosis Versus Medical Therapy for the Treatment of Ischemic Nephropathy
|
| Acronym: |
NITER
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Atherosclerosis|Chronic Kidney Disease|Hypertension, Renovascular|Ischemic Nephropathy|Renal Artery Stenosis
|
| Interventions: |
DRUG: Medical treatment|PROCEDURE: PTRS|DEVICE: renal artery stent|DEVICE: renal artery stent
|
| Outcome Measures: |
Primary: Death, Initiation of dialysis therapy or either serum creatinine increase more than 20% or reduction by > 20% in estimated clearance of creatinine (with MDRD formula), 0.5, 1 and 2 years follow up plus extended 4 yrs | Secondary: Systolic and diastolic blood pressure values at 0.5, 1 and 2 yrs follow up, with an extended follow up after 2 yrs, 0.5, 1 and 2 years follow up plus extended 4 yrs|Number of hypotensive drugs, 0.5, 1 and 2 years follow up plus extended 4 yrs|Results of renal scintigraphy, 0.5, 1 and 2 years follow up plus extended 4 yrs|Incidence of complications due to interventional manoeuvres, 0.5, 1 and 2 years follow up plus extended 4 yrs|Changes in the incidence of vascular complications in extra-renal districts, 0.5, 1 and 2 years follow up plus extended 4 yrs
|
| Sponsor/Collaborators: |
Sponsor: Azienda Unita Sanitaria Locale di Piacenza
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
80
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2003-10
|
| Completion Date: |
2009-05
|
| Results First Posted: |
|
| Last Update Posted: |
2009-12-02
|
| Locations: |
Divisione di Nefrologia e Dialisi, "Guglielmo da Saliceto" Hospital, Azienda USL Piacenza, Piacenza, 29100, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT01023373
|
