Feramyl® PK and safety trial in patients suffering from anaemia following cardiac surgery

Phase 1

• Conditions: Post-operative iron defieciency; MedDRA version: 19.0Level: LLTClassification code 10002062Term: Anaemia iron deficiencySystem Organ Class: 100000004851; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2015-003069-28-DK
• Lead Sponsor: Serumwerk Bernburg AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-11
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Signed informed consent given prior to any trial procedures performed
2. Male or female aged = 18years at the time of signing the informed consent
3. Cardiac surgery performed and the subject has a low mortality risk according to Euro SCORE II < 6 %
4. Anaemia defined as haemoglobin:
- a.200 mg and 500 mg treatment groups: Below 13.0 g/dl (8.1 mmol/L) for males and 12.0 g/dl (7.3 mmol/L) for females and TSAT < 20 %
- b.1500 mg treatment group: Below 8.1 g/dl (5 mmol/L) if bodyweight is 70-74 kg; Below 8.5 g/dl (5.3 mmol/L) if body weight is 75-79 kg; Below 9.4 g/dl (5.8 mmol/L) if body weight is 80-84 kg; Below 9.8 g/dl (6.1 mmol/L) if body weight is 85-89 kg; Below 10.3 g/dl (6.4 mmol/L) if body weight is 90 kg or above
5. Blood pressure < 145 mmHg/95 mmHg
6. Willing and able to comply with the protocol according to the investigators judgement

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

1. Body weight less than 50 kg
2.Currently experiencing an ongoing bleeding >50 ml/h for the last 3 hours before start of infusion
3.Unexplained anaemia or anaemia due to other aetiology; untreated Vitamin B12 or folate deficiency or hemoglobinopathy
4.Anticipated medical need for erythropoetin during the trial period
5.Known hypersensitivity to iron, hydroxyethylstarch or any excipients of the investigational products
6.Known drug allergy, immunological or inflammatory diseases, severe asthma, eczema or atopy
7.Preoperative anaemia treatment within 3 months prior to screening
8.Ferritin > 800 ng/ml
9.Imminent dialysis
10.Infection (T > 38.5°C or subject on non-prophylactic antibiotics)
11.Chronic liver disease or screening ALAT or ASAT above three times the upper limit of the normal range
12.Renal disease defined as proteinuria and s-creatinine > 150 µmol/l
13.Primary hematologic disease
14.Known malignant disease/cancer within the last 5 years
15.Insulin treated diabetes
16.Rheumatoid arthritis with active joint inflammation
17.History (current or past) of drug or alcohol abuse
18.Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods as required by local regulations and practice
19.Known or suspected of not being able to comply with the trial protocol (e.g. due to psychological disorders or other conditions).
20.Receipt of any investigational medicinal products within the last 90 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified