NCT00646035

Brief Summary

To determine the safety and efficacy of paricalcitol capsules as compared to placebo for treatment of secondary hyperparathyroidism by decreasing serum intact parathyroid hormone levels in end stage renal disease subjects on peritoneal dialysis.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at below P25 for phase_3

Geographic Reach
2 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
Last Updated

March 28, 2008

Status Verified

March 1, 2008

Enrollment Period

10 months

First QC Date

March 26, 2008

Last Update Submit

March 26, 2008

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

  • The achievement of two consecutive greater than or equal to 30% decreases from baseline iPTH levels.

    12 weeks

  • The incidence of clinically meaningful hypercalcemia and elevated Ca x P.

    12 weeks

Study Arms (2)

A

PLACEBO COMPARATOR
Drug: paricalcitol capsules

B

PLACEBO COMPARATOR
Drug: paricalcitol capsules

Interventions

paricalcitol capsulesDRUG

baseline iPTH/60

Also known as: ABT-358, Zemplar, paricalcitol
AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is greater than or equal to 18 years.
  • Subject is diagnosed with ESRD and must be on continuous PD 7 days per week for at least 2 months prior to Screening Phase.
  • If female, subject is either not of childbearing potential or is of childbearing potential and practicing one of the recommended methods of birth control.
  • If female, subject must have a negative serum pregnancy test prior to treatment.
  • If female, subject is not breastfeeding.
  • Subject is undergoing full PD regimen and is expected to remain on this PD regimen for the duration of the study.
  • For those subjects who have been taking a phosphate binder prior to therapy, the subject has been on a stable type of phosphate binder at least 4 weeks prior to the Pre-Treatment Phase.
  • For entry into the Pretreatment Phase the subject must have: Calcium level less than or equal to 10.5 mg/dL and Ca x P level less than or equal to 65.
  • For entry into the Treatment Phase the subject must have: iPTH greater than or equal to 300 pg/mL, calcium level of 8.0 to 10.5 mg/dL, inclusive, and Ca x P less than or equal to 65.
  • Subject has voluntarily signed and dated an IRB approved informed consent.

You may not qualify if:

  • Subject has history of an allergic reaction or significant sensitivity to drugs similar to the study drug
  • Subject has had active peritonitis within 1 month prior to screening phase.
  • Subject has had more than one episode of peritonitis within 4 months prior to screening phase.
  • Subject has received a partial parathyroidectomy within 1 year prior to screening phase.
  • Subject has had acute renal failure within 3 months of screening phase.
  • Subject has chronic gastrointestinal disease.
  • Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the screening phase or will require these medications greater than 3 weeks in the study.
  • Subject has a current malignancy or clinically significant liver disease.
  • Subject has a history of drug or alcohol abuse within 6 months prior to screening phase.
  • Subject has evidence of poor compliance with diet, medication, or PD.
  • Subject has participated in any investigational drug or device study within 4 weeks prior to the treatment phase.
  • Subject is taking maintenance calcitonin, glucocorticoids, or other drugs that may affect calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy.
  • For any reason, subject is considered by the investigator to be an unsuitable candidate to receive paricalcitol capsules.
  • Subject is known to be HIV positive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Unknown Facility

Los Angeles, California, 90095, United States

Location

Unknown Facility

Denver, Colorado, 80230, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20007, United States

Location

Unknown Facility

Fort Myers, Florida, 33919, United States

Location

Unknown Facility

Tampa, Florida, 33603, United States

Location

Unknown Facility

Savannah, Georgia, 31405, United States

Location

Unknown Facility

Evanston, Illinois, 60201, United States

Location

Unknown Facility

Maywood, Illinois, 60153, United States

Location

Unknown Facility

Indianapolis, Indiana, 46202, United States

Location

Unknown Facility

New Orleans, Louisiana, 70112, United States

Location

Unknown Facility

St Louis, Missouri, 63110, United States

Location

Unknown Facility

Las Vegas, Nevada, 89102, United States

Location

Unknown Facility

Mineola, New York, 11501, United States

Location

Unknown Facility

Cincinnati, Ohio, 45206, United States

Location

Unknown Facility

Cincinnati, Ohio, 45220, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Portland, Oregon, 97210, United States

Location

Unknown Facility

Charleston, South Carolina, 29425, United States

Location

Unknown Facility

Memphis, Tennessee, 38105, United States

Location

Unknown Facility

Nashville, Tennessee, 37205, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Lubbock, Texas, 79430, United States

Location

Unknown Facility

Krakow, 30-501, Poland

Location

Unknown Facility

Krakow, Poland

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 28, 2008

Study Start

January 1, 2002

Primary Completion

November 1, 2002

Last Updated

March 28, 2008

Record last verified: 2008-03

Locations

US(22)PL(2)