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Use of Calcimimetics vs oral Paricalcitol in Renal transplant Patients affected with Persistent Secondary Hyperparathyroidism. A pilot study - ND

Use of Calcimimetics vs oral Paricalcitol in Renal transplant Patients affected with Persistent Secondary Hyperparathyroidism. A pilot study - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-021041-42-IT
Enrollment
Unknown
Registered
2010-10-08
Start date
2011-01-28
Completion date
Unknown
Last updated
2012-04-03

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

Conditions

Renal transplant patients MedDRA version: 9.1 Level: LLT Classification code 10020708

Interventions

Trade Name: ZEMPLAR Pharmaceutical Form: Capsule, soft INN or Proposed INN: Paricalcitol Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 1- Trade Name: MIMPARA Ph

Sponsors

AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Inclusion criteria in Lead-in: Patient has received renal transplant more than 6 months before enrolment. Persistent secondary hyperparathyroidism after renal transplantation, intended as: Serum PTH higher than reference KDOQI range for the individual renal function. Serum Ca level:>10,5 mg/dL and = 15 mL/min 2)Entry criteria at baseline (after 4 weeks cinacalcet lead-in): Subjects should have a serum Ca level less than 10,2 mg/dL. 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: 70 years of age. Participant to other studies in the last 30 days. Acute rejection. Acute intercurrent illness. Life expectancy =10 mg/day of prednisone or equivalent)(except topical or inhaled glucocorticoids). Pregnant (confirmed by screening pregnancy test) or lactating females. Drugs intolerance. For any reason, subject is considered by the Investigator to be an unsuitable candidate to receive paricalcitol capsules and/or cinacalcet or is put at risk by study procedures.Subjects with serum Ca equal or greater than 10.2 mg/dL after the 4-week lead-in phase will be excluded from the study

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the efficacy of oral Paricalcitol in reduction of PTH levels in renal transplant patients previously treated with Cinacalcet.;Secondary Objective: No Secondary objectives Specified;Primary end point(s): Proportion reduction of PTH levels with respect to baseline—

Countries

Italy

Outcome results

None listed

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