Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose
This study has been completed.
Sponsor:
Abbott
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00891813
First received: April 29, 2009
Last updated: September 22, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Secondary Hyperparathyroidism Renal Insufficiency, Chronic Parathyroid Hormone Hemodialysis Hypercalcemia |
Drug: Zemplar (paricalcitol) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 100 |
| Study Start Date: | May 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Zemplar (paracalcitol) |
Drug: Zemplar (paricalcitol)
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:
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891813
Locations
| Peru | |
| Site Reference ID/Investigator# 21401 | |
| Callao, Peru, CALLAO 2 | |
| Site Reference ID/Investigator# 23857 | |
| Lima, Peru, Lima-11 | |
| Site Reference ID/Investigator# 10941 | |
| Lima, Peru | |
Sponsors and Collaborators
Abbott
Investigators
| Study Director: | Oscar E Guerra, MD | Abbott |
More Information
No publications provided
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00891813 History of Changes |
| Other Study ID Numbers: | W10-677 |
| Study First Received: | April 29, 2009 |
| Results First Received: | September 22, 2011 |
| Last Updated: | September 22, 2011 |
| Health Authority: | Peru: Ministry of Health |
Additional relevant MeSH terms:
|
Hypercalcemia Hyperparathyroidism Hyperparathyroidism, Secondary Renal Insufficiency Renal Insufficiency, Chronic Calcium Metabolism Disorders Metabolic Diseases Water-Electrolyte Imbalance Parathyroid Diseases Endocrine System Diseases |
Kidney Diseases Urologic Diseases Ergocalciferols Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on June 18, 2013