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Completed

NCT Number: NCT00828737

Safety of Gadovist in Renally Impaired Patients

Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Gadovist, will be asked to participate.

The administration of contrast agents that contain gadolinium such as Gadovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Gadovist. Patients who are enrolled in this study will receive a Gadovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.

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Key information

Conditions

Fibrosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Impairment Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Adelaide, South Australia, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with moderate (eGFR 30 - 59 ml/min/173m2) or severe (eGFR < 30 ml/min/1.73m2) renal impairment, scheduled to undergo Gadovist-enhanced MRI

Exclusion criteria

  • GBCA-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Gadovist within 12 months prior to administration of Gadovist
  • History of NSF (Nephrogenic Fibrosing Dermopathy)
  • Age outside the indicated age range mentioned in national labelling.

Treatment and study plan

Gadobutrol (Gadovist, BAY86-4875)

Drug

Gadovist in approved indications at approved dosages

Primary outcomes

  1. Number of patients with moderate to severe renal impairment, who develop Nephrogenic Systemic Fibrosis (NSF), based on diagnostically specific clinical and histopathological information

    Time frame: From the time of MRI until the end of follow-up period (24 months)

Secondary outcomes

  1. Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy was Obtained who Develop Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical Information

    Time frame: From the time of MRI until the end of follow-up period (24 months)

  2. Number of Participants With Different Criteria of Diagnostic Confidence of the Investigator Based on

    Time frame: Immediately after Gadovist-enhanced MRI

  3. Number of Participants With Image Quality Sufficient for Diagnosis

    Time frame: Immediately after Gadovist-enhanced MRI

  4. Evaluation of Creactive Protein (CRP) in Participants With Moderate and Severe Renal Impairment

    Time frame: Within 48 hours prior to the Gadovist administration

  5. Evaluation of Macrophage Inflammatory Proteins (MIP) and Monocyte Chemotactic Proteins (MCP) in Participants With Moderate and Severe Renal Impairment

    Time frame: Within 48 hours prior to the Gadovist administration

  6. Evaluation of Osteopontin and Tissue Inhibitor of Metallo Proteinase 1 (TIMP1) in Participants With Moderate and Severe Renal Impairment

    Time frame: Within 48 hours prior to the Gadovist administration

  7. Number of Participants With Treatmentemergent Adverse Events (TEAEs), Treatmentemergent Serious Adverse Event (TESAE), Drugrelated Treatmentemergent Adverse Events (TEAEs) and Drugrelated Treatmentemergent Serious Adverse Events (TESAEs)

    Time frame: From the time of MRI until the end of follow-up period (24 months)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Prospective Non-randomized (Pharmacoepidemiologic) Cohort Study (Open-label, Multicenter) to Assess the Magnitude of Potential Risk With the Administration of Gadovist in Patients With Moderate to Severe Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical and Histopathologic Information

Acronym: GRIP

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Jan 26, 2009
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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