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Mangoral for Kidney Failure (SPARKLE Trial)

Phase 3
Waitlist Available
Led By Bernd Hamm, MD
Research Sponsored by Ascelia Pharma AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

SPARKLE Trial Summary

This trial is testing a new MRI contrast agent for people with kidney problems and possible liver lesions. The goal is to see if the agent is safe and can help doctors better see the lesions.

Eligible Conditions
  • Liver Lesions
  • Kidney Failure

SPARKLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary efficacy endpoint is the visualization of detected focal liver lesions in combined MRI (CMRI, Mangoral-enhanced MRI plus unenhanced MRI) as compared to unenhanced MRI.
Secondary outcome measures
Change(s) in patients' Management based on diagnostic Performance of CMRI or Mangoral-enhanced MRI vs. unenhanced MRI
Confidence in lesion detection separately in unenhanced MRI, Mangoral-enhanced MRI, and CMRI
Confidence in lesion localization separately in unenhanced MRI, Mangoral-enhanced MRI, and CMRI
+4 more

SPARKLE Trial Design

1Treatment groups
Experimental Treatment
Group I: MangoralExperimental Treatment1 Intervention
All participants will receive a single dose of Mangoral (equivalent to 800 mg Manganese (II) chloride tetrahydrate [MnCl2 4H2O]).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mangoral
2020
Completed Phase 3
~90

Find a Location

Who is running the clinical trial?

Ascelia Pharma ABLead Sponsor
Bernd Hamm, MDPrincipal InvestigatorCharite Berlin, Dept. of Radiology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people can join this trial at most?

"The sponsor, Ascelia Pharma AB, needs to recruit 197 patients that meet the necessary inclusion criteria for this study. Once enrolled, these participants will take place at Southwest Medical Imaging in Scottsdale, Arizona and Yale University School of Medicine in New Haven, Connecticut."

Answered by AI

Are new participants being accepted into this research study?

"This study, which was first advertised on February 19th 2020, is currently looking for volunteers according to the latest update from clinicaltrials.gov on November 7th 2022."

Answered by AI

In how many areas is this clinical trial being conducted?

"So far, 18 patients have been recruited for this trial from locations such as Southwest Medical Imaging in Scottsdale, Yale University School of Medicine in New Haven, and Mayo Clinic - Rochester in Rochester."

Answered by AI

Could you please list the potential side effects of Mangoral?

"There is existing efficacy data and multiple safety studies for Mangoral, so it received a score of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function
2020. "Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04119843.
~17 spots leftby Apr 2025
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