Treatment With 5-AminoLEvuliNic Acid Before Cardiac Surgery

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

February 1, 2021

Primary Completion Date

June 30, 2022

Study Completion Date

June 30, 2022

Conditions
Cardiac Surgical ProceduresCoronary Artery BypassAortic Valve DiseaseMitral Valve Disease
Interventions
DRUG

5-Aminolevulinic Acid hydrochloride (5-ALA)

5-ALA: supplied for oral administration as a dark green, opaque, size 0, hypromellose (HPMC) capsule containing drug alone at a dosage strength of 75mg (58.7mg as 5-ALA). There are no excipients.

OTHER

Placebo

Supplied for oral administration as a dark green, opaque, size 0, HPMC capsule containing 125mg lactose. The capsule shells are of non-animal origin, and are comprised of HPMC, titanium dioxide, and a copper complex of chlorophyllins.

DRUG

Sodium ferrous citrate (SFC)

SFC: supplied for oral administration as a dark green, opaque, size 0, HPMC capsule containing drug alone at a dosage strength 118mg (12.5mg as Fe). There are no excipients.

Trial Locations (1)

OX3 9DU

John Radcliffe Hospital, Oxford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

SBI Pharmaceuticals Co, Ltd.

INDUSTRY

collaborator

Emerald Clinical Inc.

INDUSTRY

lead

University of Oxford

OTHER