Proactive IV irOn therapy for HaemodiALysis patients (PIVOTAL)

Phase 1

• Conditions: Iron-deficiency in anaemia of end stage renal disease.; MedDRA version: 16.0 Level: LLT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 100000004857; MedDRA version: 16.0 Level: LLT Classification code 10066763 Term: Chronic iron deficiency anaemia System Organ Class: 100000004851; MedDRA version: 16.0 Level: LLT Classification code 10066623 Term: Chronic haemodialysis System Organ Class: 100000004865; MedDRA version: 16.0 Level: LLT Classification code 10014647 Term: End stage renal failure System Organ Class: 100000004857; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-002267-25-GB
• Lead Sponsor: King's College Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-17
• Study Completion: 2018-06-06
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 2141

Inclusion Criteria

-Patients > or = 18 years
- Patients established on a chronic haemodialysis programme for end-stage renal failure
- Clinically stable (Principal Investigator’s judgement)
-Within 0–12 months since commencing haemodialysis
-Ferritin < 400 ug/L
-Transferrin saturation < 30%
-On ESA (erythropoiesis stimulating agent) therapy
-Written informed consent

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 2080
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2080

Exclusion Criteria

- Life expectancy < 12 months (Principal Investigator’s judgement)
- Living-donor transplant scheduled within the next 12 months
- CRP > 50 mg/L
- Active infection
- Current active malignancy (with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia)
- Known HIV or active hepatitis B or C
- Chronic liver disease and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range
- Advanced heart failure (NYHA IV)
- Pregnancy or breast feeding
- History of acquired iron overload
- Previous severe hypersensitivity reactions to IV iron sucrose (Venofer®)
- Subject has any kind of disorder that compromises their ability to give written informed consent and/or to comply with study procedures

Study & Design

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