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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00646035
First received: March 26, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
End Stage Renal Disease
Drug: paricalcitol capsules
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • The achievement of two consecutive greater than or equal to 30% decreases from baseline iPTH levels. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The incidence of clinically meaningful hypercalcemia and elevated Ca x P. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 75
Study Start Date: January 2002
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Drug: paricalcitol capsules
baseline iPTH/60
Other Names:
  • ABT-358
  • Zemplar
  • paricalcitol
Placebo Comparator: B Drug: paricalcitol capsules
baseline iPTH/60
Other Names:
  • ABT-358
  • Zemplar
  • paricalcitol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00646035

  Show 24 Study Locations
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Keith Boardway, Abbott
ClinicalTrials.gov Identifier: NCT00646035     History of Changes
Other Study ID Numbers: 2001-015, R&D/02/655
Study First Received: March 26, 2008
Last Updated: March 26, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Ergocalciferols
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on October 20, 2014