- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00891813
Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose
September 22, 2011 updated by: Abbott
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Callao, Peru, CALLAO 2
- Site Reference ID/Investigator# 21401
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Lima, Peru, Lima-11
- Site Reference ID/Investigator# 23857
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Lima, Peru
- Site Reference ID/Investigator# 10941
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Zemplar (paracalcitol)
|
Zemplar (paricalcitol) dose will be calculated mcg=PARATHYROID HORMONE level/100; this will be provided 3 times per week.
Dose will be adjusted by 2-4 mcg every 4 weeks according to the parathyroid hormone level.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL
Time Frame: 24 weeks
|
The percentage of participants who achieved at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150 to 300 picograms per milliliter (pg/mL) at any post-baseline visit during the study.
An iPTH value of 150-300 pg/ml is the target range recommended by the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) for End Stage Renal Disease patients.
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL
Time Frame: 24 Weeks
|
Median time to achieve at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150-300 pg/mL.
|
24 Weeks
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Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65).
Time Frame: 24 Weeks
|
The number of participants with hypercalcemia (defined as at least one calcium value of more than 10.5 milligrams per deciliter [mg/dL]), hyperphosphatemia (phosphorus value of more than 6.5 mg/dL), and/or elevation of Calcium X Phosphorus product (value greater than 65) during the 24 week study.
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24 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Oscar E Guerra, MD, Abbott
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (ACTUAL)
September 1, 2010
Study Completion (ACTUAL)
September 1, 2010
Study Registration Dates
First Submitted
April 29, 2009
First Submitted That Met QC Criteria
April 30, 2009
First Posted (ESTIMATE)
May 1, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
October 31, 2011
Last Update Submitted That Met QC Criteria
September 22, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Neoplasms
- Kidney Diseases
- Urologic Diseases
- Endocrine System Diseases
- Parathyroid Diseases
- Neoplastic Processes
- Calcium Metabolism Disorders
- Water-Electrolyte Imbalance
- Renal Insufficiency, Chronic
- Hyperparathyroidism
- Neoplasm Metastasis
- Renal Insufficiency
- Hyperparathyroidism, Secondary
- Hypercalcemia
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Ergocalciferols
Other Study ID Numbers
- W10-677
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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