Trial Outcomes & Findings for Triferic IRIDA (Iron-Refractory Iron-Deficiency Anemia) Protocol (NCT NCT02905981)

NCT ID: NCT02905981

Last Updated: 2020-09-22

Results Overview

The efficacy will be done by assessing the change from baseline in hemoglobin concentration

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2020-09-22

Participant Flow

Participant milestones

Measure	All Participants In this phase 2, open-label, 3-period study all participants enrolled underwent an oral iron absorption testing with Triferic when it is administered with Shohl's solution during 3 visits during Period 1. In Period 2 (dose titration), the patients received Shohl's solution and Triferic orally up to 3 times per day for 4 months. In Period 3 patients received Shohl's solution and Triferic orally up to 3 times per day for an additional 6 months
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Triferic IRIDA (Iron-Refractory Iron-Deficiency Anemia) Protocol

Baseline characteristics by cohort

Measure	All Patients in Study n=1 Participants All patients enrolled in the study who undergoing all three periods: an oral iron absorption testing period (Period 1), a Triferic dose titration period (Period 2), a hemoglobin maintenance period (Period 3
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

The efficacy will be done by assessing the change from baseline in hemoglobin concentration

Outcome measures

Measure	All Patients in Study n=1 Participants All patients enrolled in the study who undergoing all three periods: an oral iron absorption testing period (Period 1), a Triferic dose titration period (Period 2), a hemoglobin maintenance period (Period 3
The Efficacy of Triferic Delivered to IRIDA Patients:Change in Hemoglobin (Hgb)	7.9 micrograms per deciliter

SECONDARY outcome

Timeframe: 4 months

The efficacy will be done by assessing the change from baseline in serum iron

Outcome measures

Measure	All Patients in Study n=1 Participants All patients enrolled in the study who undergoing all three periods: an oral iron absorption testing period (Period 1), a Triferic dose titration period (Period 2), a hemoglobin maintenance period (Period 3
The Efficacy of Triferic Being Delivered to Iron-refractory Iron Deficiency Anemia (IRIDA) Patients:Change in Serum Iron	19 micrograms per deciliter

SECONDARY outcome

Timeframe: 4 months

The efficacy will be done by assessing the change from baseline in TSAT

Outcome measures

Measure	All Patients in Study n=1 Participants All patients enrolled in the study who undergoing all three periods: an oral iron absorption testing period (Period 1), a Triferic dose titration period (Period 2), a hemoglobin maintenance period (Period 3
The Efficacy of Triferic Being Delivered to IRIDA Patients:Change From Baseline in Transferrin Saturation (TSAT)	6.2 micrograms per deciliter

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=1 participants at risk In this phase 2, open-label, 3-period study all participants enrolled underwent an oral iron absorption testing with Triferic when it is administered with Shohl's solution during 3 visits during Period 1. In Period 2 (dose titration), the patients received Shohl's solution and Triferic orally up to 3 times per day for 4 months. In Period 3 patients received Shohl's solution and Triferic orally up to 3 times per day for an additional 6 months
Infections and infestations Viral Infection	100.0% 1/1 • Number of events 1 • 11 months
Gastrointestinal disorders Halitosis	100.0% 1/1 • Number of events 1 • 11 months
Infections and infestations Influenza	100.0% 1/1 • Number of events 1 • 11 months

Additional Information

Ray Pratt, MD

Rockwell Medical

Phone: 248 960-9009

Email: rpratt@rockwellmed.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60