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

NCT00891813 | Completed Phase 4 Results

• 1 other identifier: W10-677
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Secondary Hyperparathyroidism; Renal Insufficiency, Chronic; Parathyroid Hormone; Hemodialysis; Hypercalcemia

Outcome Measures

Primary Outcomes (1)

• The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL

  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 Outcomes (2)

• Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL

  24 Weeks

• Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65).

  24 Weeks

Study Arms (1)

Zemplar (paracalcitol)

EXPERIMENTAL

Drug: Zemplar (paricalcitol)

Interventions

Zemplar (paricalcitol) DRUG

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.

Also known as: ABT-358, paricalcitol, Zemplar

Zemplar (paracalcitol)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (3)

Site Reference ID/Investigator# 21401

Callao, CALLAO 2, Peru

Location

Site Reference ID/Investigator# 23857

Lima, Lima-11, Peru

Location

Site Reference ID/Investigator# 10941

Lima, Peru

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Renal Insufficiency, Chronic; Hypercalcemia

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

1-800-633-9110

Study Officials

• Oscar E Guerra, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2009
• First Posted: May 1, 2009
• Study Start: May 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 31, 2011
• Results First Posted: October 31, 2011

Record last verified: 2011-09

Locations

PE (3)