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

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

Effectiveness and Safety of a 6-Month Treatment With IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose

NCT00891813•Abbott

View on ClinicalTrials.gov

Summary

The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH\>300pg/mL) and that require dialysis at least 3 times per week.

Detailed Description

The study will be carried out in three dialysis centers in Peru. Each patient enrolled in the study will be followed during a 6 month period from the time of inclusion. Study visits will occur at Baseline and at Weeks 4, 8, 12 and 24 during the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients \>=18 years old with secondary hyperparathyroidism (PTH\>300pg/mL, measured in the last 2 weeks).
•Patients on hemodialysis who require starting therapy with IV paricalcitol (de novo).
•Patients attending 3 hemodialysis sessions per week.
•Patients signing the informed consent approved by the Ethics Committee. If any individual is not capable of giving his/her consent, it can be obtained from a next of kin or from his/her legal representative, according to local laws and regulations.
•The decision to initiate treatment is upon the investigator and the decision to treat patients with IV paricalcitol must not be based on the inclusion of the patient in the study or any other way. The decision to treat a patient with IV paricalcitol will be taken prior to asking the patient to participate in the study.

Exclusion Criteria

•Patients with any concomitant clinical condition that, according to the investigator's opinion, might impede an adequate assessment of the treatment response.
•Patients with severe hyperparathyroidism (PTH\>3000pg/mL).
•Patients with a serum calcium level greater or equal to 10.5mg/dL, phosphorus greater or equal to 6.5mg/dL, or those with Calcium X Phosphorus product 65 (measured at least 2 weeks before the study).
•Patients with neoplastic disease.
•Pregnant or lactating women.
•Known hypersensitivity and/or toxicity to vitamin D metabolites and/or to other ingredients of the product.
•Having participated in another study with an investigational product or device within the previous 30 days or having planned to participate in another study within the same period of time as the actual study.
•Use of vitamin D analogue during the last 3 months prior to the inclusion to this study.

Locations (3)

Site Reference ID/Investigator# 21401

Callao, Peru

Site Reference ID/Investigator# 23857

Lima, Peru

Site Reference ID/Investigator# 10941

Lima, Peru

Key Dates

Start Date

May 1, 2009

Primary Completion Date

September 1, 2010

Completion Date

September 1, 2010

Last Updated

October 31, 2011

Enrollment

100

ACTUAL participants

Conditions

Secondary HyperparathyroidismRenal Insufficiency, ChronicParathyroid HormoneHemodialysisHypercalcemia

Interventions

Zemplar (paricalcitol)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

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