Renal Safety Evaluation After Dotarem®-Enhanced MRI

NCT00650845 | Completed Phase 4 Results DMC

• 1 other identifier: DGD-44-044
• Study Type: interventional
• Target: 135
• Locations: 4 countries
• Sites: 15

Brief Summary

Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial. The aim of this study was to evaluate the safety profile of gadoterate meglumine (Dotarem®) in patients with chronic renal insufficiency by evaluating the rate of patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate meglumine.

Conditions

Renal Insufficiency

Keywords

contrast-induced nephropathy, creatinemia

Outcome Measures

Primary Outcomes (2)

• Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of a Least 25% Over Baseline Levels, in the Full Analysis Set Population.

  Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.

  baseline pre MRI and 3 days post MRI

• Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of at Least 25% Over Baseline Levels, in the Per Protocol Population.

  Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.

  Baseline pre MRI and 3 days post MRI

Secondary Outcomes (4)

• Percent Change of Serum Creatinine Level From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population.

  Baseline pre MRI and 3 days post MRI

• Percent Change of Serum Creatinine Level Variation From Baseline to 72±24 Hours After Examination, in the Per Protocol Population

  Baseline pre MRI and 3 days post MRI

• Percent Change of Estimated Glomerular Filtration Rate (eGFR) Values From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population

  Baseline pre MRI and 3 days post MRI

• eGFR Values Variation Between Baseline and 72±24 Hours After Examination, in the Per Protocol Population

  Baseline pre MRI and 3 days post MRI

Study Arms (2)

Dotarem®-enhanced MRI

EXPERIMENTAL

Patients undergoing Dotarem®-enhanced MRI for diagnostic purposes

Drug: Dotarem®-enhanced MRI

Non-enhanced MRI

OTHER

Patients undergoing non-enhanced MRI for diagnostic purposes

Other: non-enhanced MRI

Interventions

Dotarem®-enhanced MRI DRUG

Single IV administration before MRI exam

Also known as: Gadoterate meglumine, Gadoteric acid

Dotarem®-enhanced MRI

non-enhanced MRI OTHER

non injected MRI

Also known as: unenhanced MRI

Non-enhanced MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, \> or equal 18 years ;
• Patient with a known stable renal insufficiency ;
• Patient scheduled to undergo an MRI examination to specify a diagnosis ;
• Patient able to understand and provide written informed consent to participate in the trial ;

You may not qualify if:

• Patient with a contra-indication to MRI ;
• Patient who needs hemodialysis ;
• Patient with known allergy to gadolinium chelates ;
• Patients planned to either undergo surgery or receive chemotherapy ;
• Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits ;
• Patient under guardianship and/or inability or unwillingness to cooperate with the requirements of this trial ;
• Patient with newly discovered unstable diabetes.

Sponsors & Collaborators

• Guerbet: lead

Study Sites (15)

Onze Lievevrouwziekenhuis

Aalst, 9300, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

Alg. Inwendige Ziekten -Nierziekten

Roeselare, 8800, Belgium

Location

Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

Location

Hôpital A. Calmette

Lille, 59037, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

Hopital Pitie Salpetriere

Paris, 75013, France

Location

Hopital Bichat

Paris, 75018, France

Location

Hôpital Tenon

Paris, 75020, France

Location

CHU Strasbourg

Strasbourg, 67000, France

Location

Hôpital Trousseau

Tours, 37044, France

Location

Azienda Ospedaliera Universitaria di Ferrara

Ferrara, 44100, Italy

Location

Ente Ospedaliero Ospedali Galliera,

Genova, 16128, Italy

Location

Hospital San Carlos

Madrid, 28040, Spain

Location

Hospital Dr PESET

Valencia, 46017, Spain

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

gadoterate meglumine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Pierre Desché, MD - VP Development, Medical and Regulatory Affairs.
• Organization: Guerbet

pierre.desche@guerbet-group.com

+33 1 45 91 50 00

Study Officials

• Gilbert Deray, Pr, MD, PhD

  Groupe Hospitalier Pitie-Salpetriere

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: April 2, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 9, 2015
• Results First Posted: June 9, 2015

Record last verified: 2015-03

Locations

IT (2); ES (2); FR (8); BE (3)