Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent

Bracco

Status and phase: Completed; Phase 3

Conditions: Steno-occlusive Disease

Treatments: Drug: vasovist; Drug: Multihance

Study type: Interventional

Funder types: Industry

Identifiers

NCT00415805

MH 128

Details and patient eligibility

About

This is an explorative small pilot study comparing two MRA contrast agents, one of which has been on the market for a few years and the other fairly new to the market. Since the study is explorative and designed to provide preliminary information for consideration for a future larger study, sample size is not based on statistical assumptions.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Known or suspected renovascular disease based on one of the following criteria:

  • severe hypertension
  • hypertension refractory to standard therapy
  • abrupt onset of moderate to severe hypertension at age < 35 years
  • normalized blood pressure by an ACE inhibitor in a patient with moderate or severe hypertension
  • unexplained by stable elevation of serum creatinine > 2Mg/dL
  • positive findings for stenosis from another imaging modality

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

39 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Multihance

2

Active Comparator group

Treatment:

Drug: vasovist