NCT00650845 (RESCUE) is a Phase 4 clinical trial of Dotarem®-enhanced MRI in Renal Insufficiency, sponsored by Guerbet.

Who is sponsoring NCT00650845?

NCT00650845 is sponsored by Guerbet.

What drugs are being tested in NCT00650845?

Interventions in NCT00650845: Dotarem®-enhanced MRI, non-enhanced MRI.

What condition does NCT00650845 study?

NCT00650845 studies Renal Insufficiency.

Is NCT00650845 still recruiting?

NCT00650845 is currently completed. Last updated 21 May 2015.

Are results published for NCT00650845?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-05-21 · How we verify

NCT00650845: RESCUE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Renal Safety Evaluation After Dotarem®-Enhanced MRI Compared With Non-enhanced MRI in Patients at High Risk of Developing Contrast Medium Induced Nephropathy

Completed Phase 4 Results posted Last updated 21 May 2015

What this trial tests

Phase 4 trial testing Dotarem®-enhanced MRI in Renal Insufficiency in 135 participants. Completed in 1 August 2011.

Timeline

1 January 2008

Primary endpoint
1 May 2011

1 August 2011

Quick facts

Lead sponsor	Guerbet
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	135
Start date	1 January 2008
Primary completion	1 May 2011
Estimated completion	1 August 2011
Sites	15 locations across Belgium, France, Italy, Spain

Drugs / interventions tested

Dotarem®-enhanced MRI — full drug profile →
non-enhanced MRI

Conditions studied

Renal Insufficiency — all drugs for Renal Insufficiency →

Sponsor

Guerbet — full company profile →

Who can join

18 and older, any sex, with Renal Insufficiency. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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.
Time frame: baseline pre MRI and 3 days post MRI
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.
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.
Time frame: Baseline pre MRI and 3 days post MRI
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.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study).
Deray G, Rouviere O, Bacigalupo L, Maes B, et al · · 2013 · cited 39× · PMID 23212275 · DOI 10.1007/s00330-012-2705-x

Verify or expand the search:

Other recruiting trials for Renal Insufficiency

Currently open trials in the same condition.

NCT06890208 — Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave · recruiting
NCT07001436 — A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insuffici · Phase 1 · recruiting
NCT06431789 — Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in P · recruiting
NCT06354231 — DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC · Phase 2 · recruiting
NCT05428631 — Tolerability and Safety of CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Ca · NA · recruiting

Other Guerbet trials

Trials by the same sponsor.

NCT07348640 — Evaluation of the Efficacy and Safety of Magnetic Resonance Angiography (MRA) Using Gadopiclenol Compared to Gadoterate · Phase 3 · not yet recruiting
NCT06057168 — Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas · Phase 3 · completed
NCT06010173 — Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children · Phase 3 · completed
NCT05590884 — Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age · Phase 2 · completed
NCT05316077 — Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Fo · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00650845 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Guerbet
Last refreshed: 21 May 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00650845.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing