Iron treatment in patients with known kidney disease

Phase 1

• Conditions: patients with known chonic kidney disease with functional or absolute Iron deficiency Anaemia, and are greater than 18 years will be given repleacement iron therapy accoring to current local protocols and NICE guidelines; MedDRA version: 15.0Level: LLTClassification code 10022973Term: Iron deficiency anaemiasSystem Organ Class: 10005329 - Blood and lymphatic system disorders

• Registration Number: EUCTR2010-020452-64-GB
• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-08
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients with established chronic kidney disease. (Stages III-V) (GFR using MDRD <60ml/min) who are to undergo iron therapy
Male, female over 18 years
Written and signed informed patient consent
No previous iron administration in the last 6 weeks
Serum ferritin levels less than 200 mcg/l and/or transferrin saturation <20%
Able to meet all study requrements

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Pregnancy
Age < 18 years
Ferritin greater than 200 mcg/l and Transferrin saturation >40%
Known allergy to iron therapy
Haemochromatosis
Parenteral iron therapy within the previous 6 weeks
Inability to co-operate with study protocol
Patients with potential confounding factors to NGAL measurement
Patients who do not have renal failure (CKD stage I and II)
Patients who are unable or do not wish to give consent.
Patients being investigated for potential blood loss
Patients with a haematological malignancy/ haemolysis
Patients with known haemaglobinopathy
Patients with a diagnosis of myeloma
current smokers
Any other contraindications to Monofer, Venofer or Cosmofer therapy listed on SPC

Study & Design

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