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

Primary Purpose

Secondary Hyperparathyroidism, Renal Insufficiency, Chronic, Parathyroid Hormone

Status

Completed

Phase

Phase 4

Locations

Peru

Study Type

Interventional

Intervention

Zemplar (paricalcitol)

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Site Reference ID/Investigator# 21401
Site Reference ID/Investigator# 23857
Site Reference ID/Investigator# 10941

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zemplar (paracalcitol)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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).

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.

Full Information

NCT ID

NCT00891813

First Posted

April 29, 2009

Last Updated

September 22, 2011

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT00891813

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zemplar (paracalcitol)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Zemplar (paricalcitol)

Other Intervention Name(s)

ABT-358, paricalcitol, Zemplar

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

24 Weeks

Title

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

Description

Time Frame

24 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oscar E Guerra, MD

Organizational Affiliation

Abbott

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 21401

City

Callao

ZIP/Postal Code

CALLAO 2

Country

Peru

Facility Name

Site Reference ID/Investigator# 23857

City

Lima

ZIP/Postal Code

Lima-11

Country

Peru

Facility Name

Site Reference ID/Investigator# 10941

City

Lima

Country

Peru

12. IPD Sharing Statement

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

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