The Effects of Paricalcitol capsules on Inflammation (CRP levels) and Calcification regulation (fetuin-A levels) in CKD stage 5D patients - EPIC-CKD

• Conditions: Chronic kidney disease; MedDRA version: 9.1Level: LLTClassification code 10064848Term: Chronic kidney disease

• Registration Number: EUCTR2007-006606-16-DE
• Lead Sponsor: niversity of Wuerzburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

- Haemodialysis patients with age 18 years or older
- Time since initiation of dialysis >= 6 months <= 5 years
- no pre-existing therapy with active vitamin d analogue or pausing of active therapy for
minimum 1 month (washout)
- calcium < 10.2 mg/dl and serum phosphat < 6.5 mg/dl at begin of study
- iPTH blood level 200 - 600 pg/ml (at begin of study or 1 month after wash out)
- 25-OH-vitamin D blood level > 20 ng/ml
- modifications in phosphat binding therapy, dialysate calcium concentration, diet and time
of dialysis are allowed (following clinical standard treatment)
- females of childbearing potential: must have a negative pregnancy test and are requested to use a reliable method of contraception (Implant, oral contraceptive, injection, sexual abstinence or sterilisation of partner)
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- acute infection
- unstable cardiovascular disease (coronary heart disease, decompensate heart failure,
acute myocardial infarction within 6 months before screening)
- malignant tumour except non-metastasizing skin tumours
- clinical relevant gastrointestinale disorders (diarrhoea, resorption disorders, active
hepatitis, icterus)
- therapy with calcimimetic agents
- participation in another clinical trial
- pregnancy or lactation

Study & Design

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