Trial Outcomes & Findings for Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure (NCT NCT00318812)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

55 participants

Primary outcome timeframe

6 months

Results posted on

2016-05-10

Participant Flow

May 2007 - February 2011, 55 Chronic Kidney Disease patients \>18years,with an estimated Glomerular Filtration Rate (eGFR) \<30mls/minute and Hemoglobin (Hgb) of 90-110 were recruited. Recruitment was expanded to eGFR ≤60 and Hgb of 90-120g/L (females)and 90-135 g/L (males) with serum ferritin \< 100 mcg /L or Transferrin Saturation (TSAT) \< 20%)

15 of the 55 patients were screen failures due to; Hgb too high/low, ferritin level too high, Vitamin B level too low,one had bypass surgery

Participant milestones

Participant milestones
Measure	Heme Iron Heme Iron Polypeptide 11mg PO tid for 6 months	Iron Sucrose Iron Sucrose q month IV x 6 months
Overall Study STARTED	18	22
Overall Study COMPLETED	18	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Heme Iron n=18 Participants Heme Iron Polypeptide 11mg PO tid for 6 months	Iron Sucrose n=22 Participants Iron Sucrose q month IV x 6 months	Total n=40 Participants Total of all reporting groups
Age, Continuous	76 years n=5 Participants	66 years n=7 Participants	68 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment Canada	18 participants n=5 Participants	22 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Heme Iron n=18 Participants Heme Iron Polypeptide 11mg PO tid for 6 months	Iron Sucrose n=22 Participants Iron Sucrose q month IV x 6 months
Hemoglobin Concentration at 6 Months	117 g/L Interval 110.0 to 129.0	113 g/L Interval 108.0 to 120.0

SECONDARY outcome

Timeframe: 6 months

Comparison of Ferritin at 6 months between the 2 Groups

Outcome measures

Outcome measures
Measure	Heme Iron n=18 Participants Heme Iron Polypeptide 11mg PO tid for 6 months	Iron Sucrose n=22 Participants Iron Sucrose q month IV x 6 months
Ferritin	85.5 ug/L Interval 44.0 to 104.0	244 ug/L Interval 72.0 to 298.0

SECONDARY outcome

Timeframe: 6 Months

Comparison of Transferrin Saturation between the Groups

Outcome measures

Outcome measures
Measure	Heme Iron n=18 Participants Heme Iron Polypeptide 11mg PO tid for 6 months	Iron Sucrose n=22 Participants Iron Sucrose q month IV x 6 months
Transferrin Saturation	21.5 percentage of bound iron sites Interval 17.0 to 29.0	21.5 percentage of bound iron sites Interval 17.0 to 27.0

Adverse Events

Heme Iron

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Iron Sucrose

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Heme Iron n=18 participants at risk Heme Iron Polypeptide 11mg PO tid for 6 months	Iron Sucrose n=22 participants at risk Iron Sucrose q month IV x 6 months
Gastrointestinal disorders constipation	27.8% 5/18 • Number of events 5	18.2% 4/22 • Number of events 4
Gastrointestinal disorders abdominal cramps	27.8% 5/18 • Number of events 5	13.6% 3/22 • Number of events 3
Cardiac disorders Symptomatic Hypotension	0.00% 0/18	13.6% 3/22 • Number of events 3
Gastrointestinal disorders Diarrhoea	11.1% 2/18 • Number of events 2	13.6% 3/22 • Number of events 3
Gastrointestinal disorders Dyspepsia	5.6% 1/18 • Number of events 1	13.6% 3/22 • Number of events 3
Skin and subcutaneous tissue disorders Skin Rash	5.6% 1/18 • Number of events 1	0.00% 0/22
Musculoskeletal and connective tissue disorders Muscle cramps	27.8% 5/18 • Number of events 5	9.1% 2/22 • Number of events 2

Additional Information

Dr Deborah Zimmerman, principal investigator

Ottawa Hospital Research Institute

Phone: 613-738-8400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place