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:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00891813
First received: April 29, 2009
Last updated: September 22, 2011
Last verified: September 2011
  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:
  • ABT-358
  • paricalcitol
  • Zemplar

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Neoplasm Metastasis
Hyperparathyroidism
Renal Insufficiency
Hyperparathyroidism, Secondary
Renal Insufficiency, Chronic
Hypercalcemia
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on September 18, 2014