Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose

Not Applicable

Completed

• Conditions: -E213 Hyperparathyroidism, unspecified; Hyperparathyroidism, unspecified; E213

• Registration Number: PER-005-09
• Lead Sponsor: ABBOTT LABORATORIOS S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-20
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients> 18 years with secondary hyperparathyroidism (PTH> 300 pg / mL measured in the last two weeks).
• Patients on a hemodialysis program that require starting treatment with Paricalcitol I.V. (de novo)
• Patients attending 3 hemodialysis sessions per week.
• Patients who sign the informed consent approved by the Ethics Committee. If any individual is not able to give consent, it can be obtained from a close relative or legal representative in accordance with local laws and regulations.
• The decision to start treatment will depend solely on the Investigator of the study and the decision to treat patients with Paricalcitol I.V. It should not be conditioned by the inclusion of the patient or in any other way in the study. The decision to treat the patient with Paricalcitol I.V. It will be taken prior to the decision to request the participation of the patient in the study.

Exclusion Criteria

• Patients with any concomitant clinical condition that, according to the opinion of the researcher, would prevent an adequate evaluation of the response to treatment.
• Patients with severe hyperparathyroidism (PTH> 3000 pg / mL).
• Patients with serum calcium levels> 10.5 mg / dL, phosphorus> 6.5 mg / dL or those with calcium product x phosphorus> or = 65 (measured at least 2 weeks before).
• Patients with neoplastic disease.
• Women who are pregnant or breastfeeding.
• Hypersensitivity and / or known toxicity to the metabolites of vitamin D and / or other ingredients of the product.
• Have participated in another study with a drug or device under investigation within the previous 30 days or have planned to participate in another trial within the same time period of the current trial.
• Use of vitamin D analogues during the last 3 months prior to inclusion in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified