RENO- OG KREDSLØBSPROTEKTIV EFFEKT AF VITAMIN-D-ANALOG (PARICALCITOL) HOS PATIENTER MED MODERAT TIL SVÆR KRONISK NYREINSUFFICIENS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017619-14-DK

Enrollment

Registered

2010-02-16

Start date

2010-03-26

Completion date

Unknown

Last updated

2021-08-02

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

Conditions

The aim is to measure the effect of paricalcitol given orally in patients with moderate to severe chronic kidney diseases (CKD stage III-IV i.e. eGFR:15-59 ml/min) investigating vasoactive hormones, renal function, calcium metabolism, inflammatory markers, 24-hour ambulatory blood pressure, the nitric oxide system, central blood pressure, pulse wave velocity and augmentation index. MedDRA version: 12.1 Level: LLT Classification code 10064848 Term: Chronic kidney disease

Interventions

Trade Name: Zemplar Pharmaceutical Form: Capsule, soft CAS Number: 131918-61-1 Other descriptive name: PARICALCITOL Concentration unit: µg microgram(s) Concentration type: equal Concentration number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age 18-65 years • Renal disease corresponding to CKD stage 3-4 (eGFR: 15-59 ml/min) • Both men and women • Albuminuria > 500 mg/l 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: • Medical history or clinical signs diseases in connective tissue, lungs, liver, endocrine organs • Former total parathyroidectomy • Diabetes • Malignant disease • Illicit drug use • Alcohol abuse (according to the recommendations from The Danish National Board of Health) • Pregnancy or nursing • Ongoing NSAID or corticosteroid treatment • Severe anemia (b-hemoglobin 170/105 mmHg that despite antihypertensive treatment still is > 170/105 mmHg when using home blood pressure measurements or 24-hour ambulatory blood pressure measurement according to the department’s clinical guidelines.

Design outcomes

Primary

Measure	Time frame
Main Objective: Plasma renin concentration (PRC);Secondary Objective: • Urinary albumin excretion • GFR, u-Na, u-K, CNa, CK, FENa ,FEK, CH2O, u-AQP2, u-ENaCß , u-NCC • p-Aldo, p-Ang II, p-AVP, p-ANP, p-BNP, p-Endot • 24-hour ambulatory BP • Central BP, pulse wave velocity, augmentation index • p-Ca++, u-Ca, p-P, p-alkaline phosphatase, p-PTH, p-25-OH-vitamin D • p-hsCRP, p-TNFa and p-TGFß ;Primary end point(s): Plasma renin concentration (PRC)	—

Measure

Time frame

Main Objective: Plasma renin concentration (PRC);Secondary Objective: • Urinary albumin excretion • GFR, u-Na, u-K, CNa, CK, FENa ,FEK, CH2O, u-AQP2, u-ENaCß , u-NCC • p-Aldo, p-Ang II, p-AVP, p-ANP, p-BNP, p-Endot • 24-hour ambulatory BP • Central BP, pulse wave velocity, augmentation index • p-Ca++, u-Ca, p-P, p-alkaline phosphatase, p-PTH, p-25-OH-vitamin D • p-hsCRP, p-TNFa and p-TGFß ;Primary end point(s): Plasma renin concentration (PRC)

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Countries

Denmark

Outcome results

None listed

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