The Iron and Muscle Study

PHASE4CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

April 26, 2019

Primary Completion Date

December 21, 2021

Study Completion Date

February 21, 2022

Conditions
CKD Stage 3CKD Stage 4Iron-deficiency
Interventions
DRUG

Ferinject

"Active study medication Medication name: Ferinject® Active ingredient: Ferric carboxymaltose Dosage form: 50 mg iron/ml solution for injection/infusion. Appearance: Dark brown, non-transparent aqueous solution Excipients: Sodium hydroxide, hydrochloric acid and water for injection Strength/Packaging: Each 2 ml vial contains 100 mg of iron as ferric carboxymaltose.~Each 10 ml vial contains 500 mg of iron as ferric carboxymaltose. Each 20 ml vial contains 1,000 mg of iron as ferric carboxymaltose. Manufacturer: Vifor Pharma UK Limited"

OTHER

Placebo: NaCl (sodium chloride 0.9%)

Medication name: NaCl (sodium chloride 0.9%) Active ingredient: NaCl (sodium chloride 0.9%) Dosage form: 0.9% w/v NaCl as sterile solution in water for injection Excipients: Water Strength/Packaging: 100 ml container with 100 ml normal saline Manufacturer: As per local hospital supplier

Trial Locations (1)

SE5 9RS

King's College Hospital NHS Foundation Trust, London

All Listed Sponsors
collaborator

King's College London

OTHER

collaborator

University of Leicester

OTHER

lead

King's College Hospital NHS Trust

OTHER

NCT04862715 - The Iron and Muscle Study | Biotech Hunter | Biotech Hunter