A Placebo Study Comparing Intravenous Iron with Saline in Treatment of Low Blood Count before Surgery in Patients with Cancer of the Kidney, Bladder or Lower Abdominal Cavity

Phase 1

• Conditions: Iron deficiency anaemia and anaemia of chronic disease; MedDRA version: 17.1Level: LLTClassification code 10022974Term: Iron deficiency anemiaSystem Organ Class: 100000004851; MedDRA version: 17.1Level: LLTClassification code 10020970Term: Hypochromic anaemia of chronic diseaseSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-004979-13-DK
• Lead Sponsor: Rigshospitalet, 2032

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-29
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Anaemia: males Hb< 13g/dL (8.0 mmol/L), females Hb< 11.3 g/dL (7.0 mmol/L)
•Age > 18 years
•Iron deficiency anaemia and anaemia of chronic disease: P-Ferritin<100ug/L eller P-Ferritin 100-800ug/L og TSAT<20 %
•Able to give informed consent vulantary

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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

•Anaemia< Hb= 8 g/dL (5.0mmol/L) or anaemia related to other causes than iron deficiency anaemia and anaemia of chronic disease
•Known hypersensibility to intravenous iron
•Acute or chronic infection (assessed by clinical judgement supplied with WBC and CRP)
•Decompensated liver cirrhosis or hepatitis (ALAT>3x normal)
•Rheumatoid arthritis with symptoms or signs of acute inflammation (assessed by clinical judgement and CRP)
•Haemosiderosis or haemochromatosis
•RBC transfusion two weeks prior inclusion
•Intravenous iron or ESA four weeks prior inclusion
•Uraemia with creatinine>250 umol/L or haemodialysis
•Pregnancy
•Participating in another clinical study

Study & Design

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