Tralement Versus a Fixed-dose Trace Element Combination Product to Evaluate Manganese Safety

NCT05661682 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: TE20001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Tralement versus a fixed-dose trace element combination product of zinc, copper, and selenious acid to evaluate product safety in adult patients requiring long-term parenteral nutrition.

Conditions

Manganese Safety in Adults

Outcome Measures

Primary Outcomes (1)

• To assess brain deposition of manganese in Tralement versus a fixed-dose trace element product of zinc, copper, and selenious acid.

  Change from baseline in basal ganglia index (BG-index) as determined by T1-weighted brain MRI images.

  6 Months

Secondary Outcomes (1)

• To assess the efficacy & safety of Tralement versus a fixed-dose trace element product of zinc, copper, and selenious acid.

  6 Months

Study Arms (2)

Tralement

ACTIVE COMPARATOR

This study will enroll new prescribed home parenteral nutrition users, i.e. a patient enrolled in the study within six weeks of initiating first-time use of parenteral nutrition formulation requiring trace element additives. Note: a portion of patients who meet inclusion criteria may have received parenteral nutrition in an inpatient setting before discharge home.

Drug: Tralement

a fixed-dose trace element combination product of zinc sulfate, copper sulfate, and selenious acid

ACTIVE COMPARATOR

This study will enroll new prescribed home parenteral nutrition users, i.e. a patient enrolled in the study within six weeks of initiating first-time use of parenteral nutrition formulation requiring trace element additives. Note: a portion of patients who meet inclusion criteria may have received parenteral nutrition in an inpatient setting before discharge home.

Drug: Fixed-dose trace element combination product of zinc, copper, and selenious acid

Interventions

Tralement DRUG

Tralement with Manganese Sulfate

Also known as: manganese sulfate, zinc sulfate, copper sulfate, and selenious acid

Tralement

Fixed-dose trace element combination product of zinc, copper, and selenious acid DRUG

Tralement without Manganese Sulfate

Also known as: zinc, copper, and selenious acid

a fixed-dose trace element combination product of zinc sulfate, copper sulfate, and selenious acid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 to ≤80 years of age) participants able to provide informed consent.
• Male and female participants who are new users to home parenteral nutrition as a source of trace elements when oral or enteral nutrition is not possible, insufficient, or, contraindicated.
• Anticipated duration of home parenteral nutrition use is 6 months or greater.
• A normal baseline brain MRI scan.
• A normal blood manganese concentration.
• Ability to undergo additional 2 brain MRI scans over the six-month study period (Sedation, if appropriate, to be determined by the Principal Investigator's study site, institutional review board recommendations).
• Definitive contraception for females of reproductive age.

You may not qualify if:

• Prior parenteral nutrition therapy.
• Hypersensitivity or allergy to zinc or copper.
• History of occupational exposure to manganese and documented by laboratory test results.
• Baseline ferritin ≥300 ng/mL or below 100 ng/mL.
• Baseline transferrin saturation (TSAT) ≥45 % or below 20%.
• Prior or current cholestatic liver disease defined as a clinical condition associated with decrease in bile flow due to impaired secretion by hepatocytes or to obstruction of bile flow through intra-or extrahepatic bile ducts.
• Liver function studies with transaminases greater than two-fold normal or total bilirubin \>2 mg/dL.
• Known excess environmental exposure to manganese.
• Less than 1-year expected survival, as anticipated by their primary provider.
• Current participation in another clinical trial.
• Females in pregnant state.

Sponsors & Collaborators

• American Regent, Inc.: lead

MeSH Terms

Interventions

manganese sulfate; Zinc Sulfate; Copper Sulfate; Selenious Acid; Copper; Zinc

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds; Selenium Compounds; Metals, Heavy; Elements; Transition Elements; Metals

Study Officials

• Khaled Khechen, MD

  Sr. Medical Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 22, 2022
• Study Start: February 1, 2025
• Primary Completion: October 31, 2025
• Study Completion (Estimated): December 4, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02