Trial Outcomes & Findings for Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia (NCT NCT01102413)

NCT ID: NCT01102413

Last Updated: 2015-12-03

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

351 participants

Primary outcome timeframe

Baseline, 4 weeks

Results posted on

2015-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	Monofer Injections or infusions Monofer: Infusion or injections	Iron Sulphate Oral intake Iron Sulphate: Oral intake
Overall Study STARTED	233	118
Overall Study COMPLETED	208	106
Overall Study NOT COMPLETED	25	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Monofer n=233 Participants Injections or infusions Monofer: Infusion or injections	Iron Sulphate n=118 Participants Oral intake Iron Sulphate: Oral intake	Total n=351 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	164 Participants n=5 Participants	80 Participants n=7 Participants	244 Participants n=5 Participants
Age, Categorical >=65 years	69 Participants n=5 Participants	38 Participants n=7 Participants	107 Participants n=5 Participants
Sex: Female, Male Female	141 Participants n=5 Participants	54 Participants n=7 Participants	195 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants	64 Participants n=7 Participants	156 Participants n=5 Participants
Region of Enrollment Denmark	13 participants n=5 Participants	6 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment Austria	16 participants n=5 Participants	5 participants n=7 Participants	21 participants n=5 Participants
Region of Enrollment Germany	20 participants n=5 Participants	11 participants n=7 Participants	31 participants n=5 Participants
Region of Enrollment United Kingdom	19 participants n=5 Participants	12 participants n=7 Participants	31 participants n=5 Participants
Region of Enrollment India	138 participants n=5 Participants	64 participants n=7 Participants	202 participants n=5 Participants
Region of Enrollment Poland	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Russian Federation	9 participants n=5 Participants	8 participants n=7 Participants	17 participants n=5 Participants
Region of Enrollment Sweden	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	8 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4 weeks

Population: The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.

Outcome measures

Outcome measures
Measure	Monofer n=209 Participants Injections or infusions Monofer: Infusion or injections	Iron Sulphate n=108 Participants Oral intake Iron Sulphate: Oral intake
Change in Hemoglobin (Hb) Concentration From Baseline to Week 4.	0.57 g/dL Interval -3.1 to 4.0	0.35 g/dL Interval -3.7 to 3.9

SECONDARY outcome

Timeframe: Baseline to week 8

Outcome measures

Outcome measures
Measure	Monofer n=210 Participants Injections or infusions Monofer: Infusion or injections	Iron Sulphate n=112 Participants Oral intake Iron Sulphate: Oral intake
Change in Hemoglobin Concentration From Baseline to Week 8	0.92 g/dL Interval -1.6 to 5.1	0.45 g/dL Interval -2.9 to 4.0

Adverse Events

Monofer

Serious events: 12 serious events

Other events: 48 other events

Deaths: 0 deaths

Iron Sulphate

Serious events: 10 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Monofer n=228 participants at risk Injections or infusions Monofer: Infusion or injections	Iron Sulphate n=117 participants at risk Oral intake Iron Sulphate: Oral intake
Gastrointestinal disorders Diarrhoea	2.6% 6/228 • Number of events 6 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	3.4% 4/117 • Number of events 4 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Gastrointestinal disorders Faeces discoloured	0.00% 0/228 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	4.3% 5/117 • Number of events 5 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Gastrointestinal disorders Vomiting	2.6% 6/228 • Number of events 7 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.85% 1/117 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
General disorders Odema peripheral	2.2% 5/228 • Number of events 5 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	1.7% 2/117 • Number of events 2 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
General disorders Pyrexia	3.1% 7/228 • Number of events 7 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	3.4% 4/117 • Number of events 4 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Infections and infestations Nasopharyngitis	3.1% 7/228 • Number of events 9 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	3.4% 4/117 • Number of events 5 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Metabolism and nutrition disorders Hyperkalaemia	2.6% 6/228 • Number of events 7 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.00% 0/117 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Musculoskeletal and connective tissue disorders Back pain	2.2% 5/228 • Number of events 5 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.00% 0/117 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Vascular disorders Hypertension	2.6% 6/228 • Number of events 6 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	1.7% 2/117 • Number of events 2 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.

Additional Information

Vice President Research & Development Department

Pharmacosmos A/S

Phone: +45 59485959

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If Pharmacosmos or its agents has not prepared a draft for submission to a peer reviewed journal prior to 1 year following completion of the study report, the investigators have the right to publish the results. Such publications are to be submitted to Pharmacosmos for comment 30 days prior to submision for publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Monofer n=228 participants at risk Injections or infusions Monofer: Infusion or injections	Iron Sulphate n=117 participants at risk Oral intake Iron Sulphate: Oral intake
Blood and lymphatic system disorders Anaemia	0.00% 0/228 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.85% 1/117 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Cardiac disorders Acute left ventricular failure	0.00% 0/228 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.85% 1/117 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Cardiac disorders Cardiac failure	0.44% 1/228 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.00% 0/117 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Cardiac disorders Cardiac failure congestive	0.44% 1/228 • Number of events 2 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.00% 0/117 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Cardiac disorders Cardiorenal syndrome	0.00% 0/228 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.85% 1/117 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Cardiac disorders Myocardial infarction	0.44% 1/228 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.00% 0/117 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Cardiac disorders Ventricular tachycardia	0.44% 1/228 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.00% 0/117 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Gastrointestinal disorders Diarrhoea	0.44% 1/228 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.00% 0/117 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Gastrointestinal disorders Gastric ulcer	0.00% 0/228 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.85% 1/117 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Gastrointestinal disorders Oesophagitis	0.00% 0/228 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.85% 1/117 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Hepatobiliary disorders Cholangitis	0.00% 0/228 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.85% 1/117 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Immune system disorders Hypersensitivity	0.88% 2/228 • Number of events 2 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.00% 0/117 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Infections and infestations Plasmodium falciparum infection	0.44% 1/228 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.00% 0/117 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Infections and infestations Pneumonia	0.88% 2/228 • Number of events 2 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.85% 1/117 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Infections and infestations Pneumonia staphylococcal	0.00% 0/228 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.85% 1/117 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Infections and infestations Urinary track infection	0.44% 1/228 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.00% 0/117 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Injury, poisoning and procedural complications Fall	0.44% 1/228 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.00% 0/117 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Nervous system disorders Carotid artery stenosis	0.44% 1/228 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.00% 0/117 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Nervous system disorders Dizziness	0.44% 1/228 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.00% 0/117 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Nervous system disorders Polyneuropathy	0.00% 0/228 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.85% 1/117 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Nervous system disorders Syncope	0.00% 0/228 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.85% 1/117 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Renal and urinary disorders Renal failure acute	0.44% 1/228 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.00% 0/117 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.44% 1/228 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.00% 0/117 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Vascular disorders Hypertension	0.44% 1/228 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.00% 0/117 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
Vascular disorders Intermittent claudication	0.00% 0/228 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.	0.85% 1/117 • Number of events 1 The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.