Nephrogenic Fibrosing DermopathyPhase 4NCT04776187
Safety Evaluation of Linear and Macrocyclic Gadolinium Based Contrast Agents for Patients With Mild to Moderate Renal Insufficiency Undergoing Enhanced Magnetic Resonance Imaging
A Phase 4 study testing Gadodiamide and Gadoteric Acid Meglumine Salt in people with Nephrogenic Fibrosing Dermopathy, run by The Central Hospital of Lishui City at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety of linear and macrocyclic gadolinium-based contrast agents for patients with mild to moderate renal insufficiency. The study will compare the incidence of adverse events of gadodiamide and gadoteric Acid Meglumine Salt for patients with mild to moderate renal… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nephrogenic Fibrosing Dermopathy
- What is being tested?
- Gadodiamide and Gadoteric Acid Meglumine Salt
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 years old who require gadolinium-based CE-MRI;
- Patients with renal function 30ml/min/1.73m2≤eGFR<90/min/1.73m2;
- Patients who are able and willing to comply with the required inspection requirements.
Who cannot join
- Patient who experienced allergic reactions to previous gadolinium-based contrast agents;
- Patient who had used gadolinium-based contrast agents within 3 months;
- Patient with acute renal failure;
- Patient who cannot comply with or cannot tolerate the necessary fluid replenishment procedures;
- Patient with major mental illness, impaired consciousness, or other diseases considered by researchers to affect observation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lishui Central Hospital
Lishui, Zhejiang, 323000
Jiansong S Ji, MD,PhD, 2285018 ext. 0578, lschrjjs@163.com
About this study
Official title: Safety Evaluation of Linear and Macrocyclic Gadolinium-Based Contrast Agents for Patients With Mild to Moderate Renal Insufficiency Undergoing Enhanced Magnetic Resonance Imaging (Interventional Prospective Study) Clinical Trial Protocol
The purpose of this study is to evaluate the safety of linear and macrocyclic gadolinium-based contrast agents for patients with mild to moderate renal insufficiency. The study will compare the incidence of adverse events of gadodiamide and gadoteric Acid Meglumine Salt for patients with mild to moderate renal insufficiency undergoing enhanced magnetic resonance imaging.
Read the detailed description
According to the requirements of the study, 600 cases of patients with mild to moderate renal insufficiency were enrolled. Gadodiamide and Gadoteric acid meglumine salt were used for enhanced MRI. Observe the adverse reactions within 60 minutes of using the gadolinium contrast agents; follow up by telephone at 3, 6, 12, and 24 months after the inspection. The primary endpoint is the incidence of the various adverse events, and the secondary endpoints are changes of serum creatinine and inflammatory factors (TNF-α, hs-CRP, IL-6) before and after CE-MRI, patient skin examination and evaluation (evaluation of relevant indicators of skin biopsy).
- Conditions
- Nephrogenic Fibrosing Dermopathy
- Being tested
- Gadodiamide, Gadoteric Acid Meglumine Salt
- Keywords
- Humans, gadodiamide, MRI, Renal Insufficiency, Drug-Related Adverse Reactions
- Medical subject headings
- Nephrogenic Fibrosing Dermopathy, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GadodiamideDrug
Gadodiamide Injection(OMNISCAN™)
Gadoteric Acid Meglumine SaltDrug
Gadoteric Acid Meglumine Salt Injection(Jia Di Xian™)
| Study group | Role | What they receive |
|---|---|---|
| Gadodiamide | Active comparator | Patients who have undergone contrast-enhanced MRI using Gadodiamide contrast agent for clinical purposes.
Generic name: Gadodiamide Injection; Product name: OMNISCAN; Sample specifications: 15ml: 4.305g (a sterile solution containing 287mg/ml gadodiamide). Receives: Drug: Gadodiamide |
| Gadoteric Acid Meglumine Salt | Experimental | Patients who have undergone contrast-enhanced MRI using Gadoteric Acid Meglumine Salt contrast agent for clinical purposes.
Generic name: Gadoteric Acid Meglumine Salt Injection; Commodity name: Jia Di Xian; Sample specifications: 15ml: 5.654g (a sterile solution containing 377mg/ml gadoteric acid meglumine salt). Receives: Drug: Gadoteric Acid Meglumine Salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of various adverse events
Measured: From the date of contrast injection to the incidence of adverse events, assessd up to 60 minutes
The incidence of various adverse events
Measured: From the date of contrast injection to the incidence of adverse events, assessd up to 3 months
The incidence of various adverse events
Measured: From the date of contrast injection to the incidence of adverse events, assessd up to 6 months
The incidence of various adverse events
Measured: From the date of contrast injection to the incidence of adverse events, assessd up to 12 months
The incidence of various adverse events
Measured: From the date of contrast injection to the incidence of adverse events, assessd up to 24 months
Secondary outcomes (5)
Changes of serum creatinine before and after CE-MRI at 3 days
Measured: From the date of contrast injection to the changes of serum creatinine before and after CE-MRI, assessed up to 3 days
Changes of TNF-α before and after CE-MRI at 3 days
Measured: From the date of contrast injection to the changes of TNF-α before and after CE-MRI, assessed up to 3 days
Changes of hs-CRP before and after CE-MRI at 3 days
Measured: From the date of contrast injection to the changes of hs-CRP before and after CE-MRI, assessed up to 3 days
Changes of IL-6 before and after CE-MRI at 3 days
Measured: From the date of contrast injection to the changes of IL-6 before and after CE-MRI, assessed up to 3 days
Evaluation of relevant indicators of skin biopsy
proliferation of fibroblasts in subcutaneous tissue, thickening of collagen fiber bundles
Measured: From the date of contrast injection to the clinical manifestations appear, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Mar 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrogenic Fibrosing DermopathyStudies of the same condition, open and under way.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Central Hospital of Lishui City
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776187
- Sponsor's protocol ID
- Gadolinium 1.0
- Status last verified
- Feb 2021
- First submitted
- 11 Jan 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation of Linear and Macrocyclic Gadolinium-Based Contrast Agents for Patients With Mild to Moderate Renal Insufficiency Undergoing Enhanced Magnetic Resonance Imaging (Interventional Prospective Study) Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT04776187
- Acronym / sponsor ID
- Gadolinium 1.0
- Conditions
- Nephrogenic Fibrosing Dermopathy
- Keywords
- Humans, gadodiamide, MRI, Renal Insufficiency, Drug-Related Adverse Reactions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The Central Hospital of Lishui CityUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of linear and macrocyclic gadolinium-based contrast agents for patients with mild to moderate renal insufficiency. The study will compare the incidence of adverse events of gadodiamide and gadoteric Acid Meglumine Salt for patients with mild to moderate renal insufficiency undergoing enhanced magnetic resonance imaging.
Detailed description
According to the requirements of the study, 600 cases of patients with mild to moderate renal insufficiency were enrolled. Gadodiamide and Gadoteric acid meglumine salt were used for enhanced MRI. Observe the adverse reactions within 60 minutes of using the gadolinium contrast agents; follow up by telephone at 3, 6, 12, and 24 months after the inspection. The primary endpoint is the incidence of the various adverse events, and the secondary endpoints are changes of serum creatinine and inflammatory factors (TNF-α, hs-CRP, IL-6) before and after CE-MRI, patient skin examination and evaluation (evaluation of relevant indicators of skin biopsy).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gadodiamide | Active comparator | Drug: GadodiamidePatients who have undergone contrast-enhanced MRI using Gadodiamide contrast agent for clinical purposes. Generic name: Gadodiamide Injection; Product name: OMNISCAN; Sample specifications: 15ml: 4.305g (a sterile solution containing 287mg/ml gadodiamide). |
| Gadoteric Acid Meglumine Salt | Experimental | Drug: Gadoteric Acid Meglumine SaltPatients who have undergone contrast-enhanced MRI using Gadoteric Acid Meglumine Salt contrast agent for clinical purposes. Generic name: Gadoteric Acid Meglumine Salt Injection; Commodity name: Jia Di Xian; Sample specifications: 15ml: 5.654g (a sterile solution containing 377mg/ml gadoteric acid meglumine salt). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 80 years old who require gadolinium-based CE-MRI;
- Patients with renal function 30ml/min/1.73m2≤eGFR<90/min/1.73m2;
- Patients who are able and willing to comply with the required inspection requirements.
Key exclusion criteria (5 listed)
- Patient who experienced allergic reactions to previous gadolinium-based contrast agents;
- Patient who had used gadolinium-based contrast agents within 3 months;
- Patient with acute renal failure;
- Patient who cannot comply with or cannot tolerate the necessary fluid replenishment procedures;
- Patient with major mental illness, impaired consciousness, or other diseases considered by researchers to affect observation.
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 |
|---|---|---|
| GadodiamideGadodiamide Injection(OMNISCAN™) | Drug | Gadodiamide |
| Gadoteric Acid Meglumine SaltGadoteric Acid Meglumine Salt Injection(Jia Di Xian™) | Drug | Gadoteric Acid Meglumine Salt |
Primary outcome
The incidence of various adverse events
Time frame: From the date of contrast injection to the incidence of adverse events, assessd up to 60 minutes
The incidence of various adverse events
Time frame: From the date of contrast injection to the incidence of adverse events, assessd up to 3 months
The incidence of various adverse events
Time frame: From the date of contrast injection to the incidence of adverse events, assessd up to 6 months
The incidence of various adverse events
Time frame: From the date of contrast injection to the incidence of adverse events, assessd up to 12 months
The incidence of various adverse events
Time frame: From the date of contrast injection to the incidence of adverse events, assessd up to 24 months
5 secondary outcomes
Changes of serum creatinine before and after CE-MRI at 3 days
Time frame: From the date of contrast injection to the changes of serum creatinine before and after CE-MRI, assessed up to 3 days
Changes of TNF-α before and after CE-MRI at 3 days
Time frame: From the date of contrast injection to the changes of TNF-α before and after CE-MRI, assessed up to 3 days
Changes of hs-CRP before and after CE-MRI at 3 days
Time frame: From the date of contrast injection to the changes of hs-CRP before and after CE-MRI, assessed up to 3 days
Changes of IL-6 before and after CE-MRI at 3 days
Time frame: From the date of contrast injection to the changes of IL-6 before and after CE-MRI, assessed up to 3 days
Evaluation of relevant indicators of skin biopsy
Time frame: From the date of contrast injection to the clinical manifestations appear, assessed up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
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.
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 Gadodiamide and Gadoteric Acid Meglumine Salt in people with Nephrogenic Fibrosing Dermopathy, run by The Central Hospital of Lishui City at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 1 Mar 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiansong S Ji, MD,PhD (2285018 ext. 0578, lschrjjs@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of various adverse events (time frame: From the date of contrast injection to the incidence of adverse events, assessd up to 60 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2021.