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AtherosclerosisPhase 4NITERNCT01023373

Revascularization of Renal Artery Stenosis Versus Medical Therapy for the Treatment of Ischemic Nephropathy

A Phase 4 study testing Medical treatment, PTRS and renal artery stent in people with Atherosclerosis and Chronic Kidney Disease, run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the study is to value, in patients with chronic kidney disease and hypertension, whether medical therapy plus interventional renal artery revascularization is superior to medical therapy alone for the treatment of hemodynamically significant (>70%) atherosclerotic renal artery stenosis, diagnosed by duplex… Read more about this study

Who is it for?
Ages 45 to 80 years
What is being tested?
Medical treatment, PTRS and renal artery stent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteItaly
Study dates
Oct 2003to May 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≤ 80 years
  • Presence of ostial renal artery stenosis ≥ 70% (determined by Duplex Doppler ultrasonography and confirmed by Magnetic Resonance valuated by at least two experienced operators)
  • Serum creatinine ≤ 3 mg/dl and/or creatinine clearance (Modification of Diet in Renal Disease, MDRD formula)≥ 30 ml/min, defined as stage 3 or greater CKD based on National Kidney Foundation classification
  • Longitudinal ultrasonographic diameter of the stenotic kidney ≥ 8 cm
  • Blood pressure values ≤ 150/90 mmHg with the use of less than four hypotensives drugs

Who cannot join

  • Age > 80 years
  • Other well-known nephropathy cause of renal failure
  • Duplex doppler ultrasonography Resistive Index values >0.8
  • Total occlusion of renal artery lumen
  • Occurrence of cerebral or cardiac vascular diseases in the 6 months before the enrolment in the study
  • Malignancy with a life expectation less than one year
Show all 12Show fewer
  • Previous documented cholesterol thrombo embolization episodes (clinically, bioptically or instrumentally)
  • Liver failure
  • Cardiac failure (NYHA IV class) or instable angina
  • Well-known intolerance or contraindications to the use of iodinated contrast media, to statins or to anti platelets drugs
  • Previous renal angioplasty
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Divisione di Nefrologia e Dialisi, "Guglielmo da Saliceto" Hospital, Azienda USL Piacenza

    Piacenza, Piacenza, 29100

Other trials in Italy

About this study

Official title: Phase 4 Study of Medical Therapy Versus Medical Therapy Plus Renal Artery Stenting in Preventing the Progression of Renal Failure in Atherosclerotic Renovascular Disease

The aim of the study is to value, in patients with chronic kidney disease and hypertension, whether medical therapy plus interventional renal artery revascularization is superior to medical therapy alone for the treatment of hemodynamically significant (>70%) atherosclerotic renal artery stenosis, diagnosed by duplex doppler ultrasonography and confirmed by magnetic resonance angiography, in terms of avoidance of the progression of renal damage, control of hypertension and in reducing the cerebro and cardiovascular complications.

Read the detailed description

Atherosclerotic renovascular disease (ARVD), due to renal hypoperfusion caused by mono or bilateral renal artery stenosis (RAS), is a increasing cause of chronic kidney disease and many elderly patients start dialysis due to ARDVD. Moreover ARVD is frequently progressive and reduces life-expectancy more than other causes of end stage renal disease, with a mortality rate higher than in patients with stable angina, similar to that of patients operated for colon cancer.

Unfortunately, there is not a definite therapy to cure this disease, despite important advancements in both medical therapy and in interventional radiology. Aim of the study is to see whether percutaneous transluminal interventional radiology plus stenting (PTRS) of the renal artery offers more, in terms of both preventing the progression of renal failure and controlling the hypertension, compared with the medical therapy addressed to control hypertension, improve the dyslipidemic profile and optimise the platelet anti-aggregant therapy, following the most recent guidelines. The eligible patients will be centrally randomized to:

  1. medical treatment with hypotensive drugs (all class of hypotensive agents will be used according to single-center experience including drugs agent on renin-angiotensin-aldosterone-system, when permitted), lipid lowering therapy (namely all class of statins-or hydroxymethylglutaryl-coA reductase inhibitors)and anti-platelet (acetylsalicylate and/or ticlopidine or clopidrogel according to single-center experience) or to
  2. the same medical therapy, as previously described in group a, associated with PTRS, according to a standardized protocol, with a follow up at 2 years extended to other 2 years
Being tested
Medical treatment, PTRS, renal artery stent
Keywords
Angioplasty, Atherosclerotic reno vascular disease (ARVD), Cardio- and cerebro- vascular comorbidity, End stage renal disease (ERSD), kidney diseases, High blood pressure, Hypertension, Ischemic nephropathy, Percutaneous transluminal renal artery stenting (PTRS), Randomized controlled trials, Renal artery stenosis (RAS), Renal insufficiency, Vascular diseases
Medical subject headings
Atherosclerosis, Renal Insufficiency, Chronic, Hypertension, Renovascular, Renal Artery Obstruction, Kidney Failure, Chronic, Kidney Diseases, Hypertension, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medical treatmentDrug

    hypotensive drugs, statins and anti-platelets

  • PTRSProcedure or surgery

    Percutaneous transluminal renal artery stenting. The same medical therapy, as in group A, plus PTRS

  • renal artery stentDevice

    Non-drug intervention, percutaneous transluminal renal artery stent angioplasty

  • renal artery stentDevice

    Adding the renal artery stenting (in group B) to the optimal medical therapy (as in group A) that includes hypotensive drugs, statins and antiplatelet therapy

Study groups in NCT01023373
Study groupRoleWhat they receive
B:PTRSExperimentalB: the same medical therapy, as previously described in group A, associated with PTRS
Receives: Procedure: PTRS; Device: renal artery stent
A:medical therapyActive comparatorhypotensive drugs, statins and antiplatelet therapy
Receives: Drug: Medical treatment; Device: renal artery stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 0.5, 1 and 2 years follow up plus extended 4 yrs

Secondary outcomes (5)

  1. Systolic and diastolic blood pressure values at 0.5, 1 and 2 yrs follow up, with an extended follow up after 2 yrs

    Measured: 0.5, 1 and 2 years follow up plus extended 4 yrs

  2. Number of hypotensive drugs

    Measured: 0.5, 1 and 2 years follow up plus extended 4 yrs

  3. Results of renal scintigraphy

    Measured: 0.5, 1 and 2 years follow up plus extended 4 yrs

  4. Incidence of complications due to interventional manoeuvres

    Measured: 0.5, 1 and 2 years follow up plus extended 4 yrs

  5. Changes in the incidence of vascular complications in extra-renal districts

    Measured: 0.5, 1 and 2 years follow up plus extended 4 yrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2009 (estimated)
  2. Study startOct 2003
  3. Primary completionSep 2008 (estimated)
  4. Study completionMay 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01023373
Sponsor's protocol ID
388-2002
Acronym
NITER
Status last verified
Dec 2009
First submitted
1 Dec 2009
Last updated
2 Dec 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Scarpioni R, Michieletti E, Cristinelli L, Ugolotti U, Scolari F, Venturelli C, Cancarini G, Pecchini P, Malberti F, Maroldi R, Rozzi G, Olivetti L. Atherosclerotic renovascular disease: medical therapy versus medical therapy plus renal artery stenting in preventing renal failure progression: the rationale and study design of a prospective, multicenter and randomized trial (NITER). J Nephrol. 2005 Jul-Aug;18(4):423-8.

    PubMed 16245247

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Medical treatment, PTRS and renal artery stent in people with Atherosclerosis and Chronic Kidney Disease, run by Azienda Unita Sanitaria Locale di Piacenza at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 0.5, 1 and 2 years follow up plus extended 4 yrs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01023373, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2009.

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