A Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis

End Stage Renal Disease Clinical Trial

Official title:

A Phase III, Prospective, Placebo-Controlled, Double-Blind, Randomized, Multi-Center Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646035
• Other study ID #: 2001-015
• Secondary ID: R&D/02/655
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2008
• Last updated: March 26, 2008
• Start date: January 2002

Study information

• Verified date: March 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• paricalcitol capsules
baseline iPTH/60

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The achievement of two consecutive greater than or equal to 30% decreases from baseline iPTH levels.		12 weeks	No
Primary	The incidence of clinically meaningful hypercalcemia and elevated Ca x P.		12 weeks	Yes