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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-006606-16-DE
Enrollment
Unknown
Registered
2009-07-30
Start date
2008-07-11
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease MedDRA version: 9.1 Level: LLT Classification code 10064848 Term: Chronic kidney disease

Interventions

Trade Name: Zemplar Weichkapsel Product Name: Paricalcitol Capsules Pharmaceutical Form: Capsule* INN or Proposed INN: Paricalcitol CAS Number: 131918611 Concentration unit: µg microgram(s) Concentrat

Sponsors

University of Wuerzburg
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Haemodialysis patients with age 18 years or older - Time since initiation of dialysis >= 6 months 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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: Identify the effects of Paricalcitol Capsules on inflammation and calcification regulation in patients with chronic kidney disease;Secondary Objective: uCMGP and GlaMGP blood level Osteoprotegerin uc- and total osteocalcin IL-1ß, TNF-alpha, IL-6, IL-10;Primary end point(s): antiinflammatory and calcification inhibitory effects of the medicinal product demonstrated by measuring the surrogate parameter of inflammation (hsCRP) and calcification regulation (fetuin-a)—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026