Chronic Kidney DiseasePhase 4NCT00908310

Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)

A Phase 4 study testing Omniscan in people with Chronic Kidney Disease and Renal Insufficiency, run by GE Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI. Omniscan will be administered intravenously at the medical discretion of the prescribing physician. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease, Renal Insufficiency
What is being tested?: Omniscan
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 213 participants
Where: 1 siteUnited States
Study dates: May 2009to Sep 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject has been referred for a clinically indicated MRI examination with a gadolinium-based contrast agent.
The subject has known or suspected chronic kidney disease with an eGFR greater than or equal to 30mL and <60 mL/min/1.73 m2 as measured within 30 days prior to the planned index OMNISCAN administration.
The subject agrees to be contacted for follow-up for 24 months.

Who cannot join

Patients with known or suspected NSF based on biopsy confirmation or the onset of signs and symptoms of NSF lasting at least 7 days as follows:
skin - swelling, hardening and tightening; reddened or darkened patches; burning or itching;
eyes - yellow raised spots on whites of eyes; or
bones and muscle - stiffness in joints; difficulty in moving or straightening of arms, hands, legs or feet; bone pain especially in hips and ribs or muscle weakness.
Patients allergic to any GBCA.
Patients with chronic renal disease with a GFR <30 mL/min/1.73 m2 as measured within 30 days prior to the planned OMNISCAN administration.
Patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri operative liver transplantation period.

Trial locations and contacts

1 site in 1 country.

United States1 site

GE Healthcare
Princeton, New Jersey, 08540

Other trials in United States

About this study

Official title: A Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive OMNISCAN (Gadodiamide Injection) for Contrast-enhanced Magnetic Resonance Imaging.

Conditions: Chronic Kidney Disease, Renal Insufficiency
Being tested: Omniscan
Keywords: CKD - Chronic Kidney Disease, GBCA - Gadolinium-based contrast agent, GFR - Glomerular Filtration Rate, MRI - Magnetic Resonance Imaging, NSF - Nephrogenic Systemic Fibrosis, Known or suspected CKD with an eGFR greater than or equal to 30mL & less than 60 mL/min/1.73m2 as measured within 30 days prior to the OMNISCAN.
Medical subject headings: Renal Insufficiency, Chronic, Renal Insufficiency

What participants receive

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

OmniscanDrug
Also called Gadodiamide
OMNISCAN will be administered intravenously at the medical discretion of the prescribing physician.

Study groups in NCT00908310
Study group	Role	What they receive
Omniscan	Other	Not described Receives: Drug: Omniscan

What is being measured

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

Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF).
Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN.
Measured: Greater than or equal to 7 days post contrast administration.

Timeline

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

May 2009Sep 2013

First posted25 May 2009 (estimated)
Study startMay 2009
Primary completionJun 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by GE HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 213 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00908310
Sponsor's protocol ID: GE-041-075
Status last verified: Jul 2014
First submitted: 13 May 2009
Last updated: 17 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive OMNISCAN (Gadodiamide Injection) for Contrast-enhanced Magnetic Resonance Imaging.
ClinicalTrials.gov ID: NCT00908310
Acronym / sponsor ID: GE-041-075
Conditions: Chronic Kidney Disease, Renal Insufficiency
Keywords: CKD - Chronic Kidney Disease, GBCA - Gadolinium-based contrast agent, GFR - Glomerular Filtration Rate, MRI - Magnetic Resonance Imaging, NSF - Nephrogenic Systemic Fibrosis, Known or suspected CKD with an eGFR greater than or equal to 30mL & less than 60 mL/min/1.73m2 as measured within 30 days prior to the OMNISCAN.
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 213 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Collaborators: i3 Statprobe
Study start: May 2009
Primary completion: Jun 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 25 May 2009 (estimated)
Results: Posted 17 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Omniscan	Other	Drug: Omniscan

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

The subject has been referred for a clinically indicated MRI examination with a gadolinium-based contrast agent.
The subject has known or suspected chronic kidney disease with an eGFR greater than or equal to 30mL and <60 mL/min/1.73 m2 as measured within 30 days prior to the planned index OMNISCAN administration.
The subject agrees to be contacted for follow-up for 24 months.

Key exclusion criteria (7 listed)

Patients with known or suspected NSF based on biopsy confirmation or the onset of signs and symptoms of NSF lasting at least 7 days as follows:
Patients allergic to any GBCA.
Patients with chronic renal disease with a GFR <30 mL/min/1.73 m2 as measured within 30 days prior to the planned OMNISCAN administration.
Patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri operative liver transplantation period.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OmniscanAlso: GadodiamideOMNISCAN will be administered intravenously at the medical discretion of the prescribing physician.	Drug	Omniscan

Primary outcome

Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF).
Time frame: Greater than or equal to 7 days post contrast administration.
Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN.

Results and safety

Results posted to the registry on 17 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Omniscan	213	153

Primary outcome: Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF).

Time frame: Greater than or equal to 7 days post contrast administration.. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Omniscan n = 202
Reporting of NSF and Symptoms	3.96 (1.73 to 7.65)
Diagnosis of NSF	0.00 (0.00 to 1.81)
Biopsy confirmed NSF	0.00 (0.00 to 1.81)

Population analysed: Incidence of Nephrogenic Systemic Fibrosis (NSF)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omniscan	7 of 202 (3.5%)	0 of 202 (0%)	Not reported

Limitations and caveats (from the sponsor): As a result of the FDA reference ID: #2954949, subject enrolment was terminated at 213 subjects. All subjects (202 subjects) who received any dose of Omniscan were followed as per protocol until study completion, withdrawal, or lost-to-follow-up.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rubin Sheng, MD study director

GE Healthcare

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Omniscan in people with Chronic Kidney Disease and Renal Insufficiency, run by GE Healthcare at 1 site in United States.

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 3 inclusion and 7 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: finished, as of the sponsor's last update on 17 Jul 2014. 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 United States. 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?

Yes. Results are posted in the registry (first posted 17 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF). (time frame: Greater than or equal to 7 days post contrast administration.). 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 NCT00908310.

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 17 Jul 2014.