Safety and Efficacy Study of Paricalcitol Versus Calcitriol in the Treatment of Secondary Hyperparathyroidism

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Malaysia
Information provided by (Responsible Party):
Dr.Ong Loke Meng, Penang Hospital, Malaysia
ClinicalTrials.gov Identifier:
NCT00800358
First received: November 30, 2008
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to determine whether oral paricalcitol is safer and more efficacious compared to oral calcitriol in the treatment of hyperparathyroidism in chronic kidney disease patients undergoing dialysis.


Condition Intervention
Hyperparathyroidism
Kidney Disease
Drug: Paricalitol
Drug: Calcitriol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi Centre, Open Label, Parallel Group, Randomized Controlled Trial to Compare the Safety and Efficacy of Oral Paricalcitol Versus Oral Calcitriol in the Treatment of Secondary Hyperparathyroidism in Dialysis Patients

Resource links provided by NLM:


Further study details as provided by Penang Hospital, Malaysia:

Primary Outcome Measures:
  • More than 30% reduction in baseline iPTH concentration at 24 weeks of treatment with Paricalcitol or Calcitriol capsules. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantum of reduction in alkaline phosphatase level, Time duration to achieve the target level of iPTH. (Titration time), Serum Calcium, phosphate, Ca x Po4 product change from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Incidence of hypercalcaemic episodes [ Time Frame: Through out 24 weeks of participation from the time of enrollment ] [ Designated as safety issue: Yes ]

Enrollment: 69
Study Start Date: November 2008
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral Paricalcitol in varying doses
Drug: Paricalitol
oral paricalcitol variable daily dosing based on intact PTH level for 6 months
Other Name: Zemplar
Active Comparator: 2
Calcitriol
Drug: Calcitriol
oral calcitriol variable daily dosing based on intact PTH level for 6 months

Detailed Description:

Secondary hyperparathyroidism, a common consequence of chronic kidney disease, results from abnormal regulation of calcium and phosphate homeostasis. The early administration of calcium supplements or vitamin D attenuates the development and progression of hyperparathyroidism, preventing or retarding the emergence of many of the serious complications of chronic kidney disease. However, these vitamin D derivatives also have serious side effects, including hypercalcemia and hyperphosphatemia and, as a result, a high level of the calcium-phosphate product. These adverse outcomes have prompted the development of novel, "nonhypercalcemic" vitamin D analogues. Three of these analogues have recently been marketed for clinical use in patients with chronic kidney disease: 19-nor-1,25-dihydroxyvitamin D2 (paricalcitol), 1 -hydroxyvitamin D2 (doxercalciferol), and 22-oxacalcitriol.

Oral paricalcitol was developed to provide a convenient, alternative therapy, particularly for Peritoneal Dialysis patients in whom regular intravenous administration of paricalcitol is not practical. This study is designed to determine the proportion of patients with 'End stage renal failure' on haemodialysis or peritoneal dialysis and secondary hyperparathyroidism who achieved more than 30% reduction in baseline iPTH concentration at 24 weeks of treatment with Paricalcitol or Calcitriol capsules.

  Eligibility

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

Inclusion Criteria:

  • Age at or above 18 years
  • End stage renal disease on regular maintenance haemodialysis or peritoneal dialysis for at least 3 months
  • iPTH level of 300 pg/ml or greater at baseline
  • Written informed consent by subject or guardian
  • Female patients will either be post-menopausal for more than 2 years, surgically sterile or if of childbearing age, using double contraception

Exclusion Criteria:

  • Baseline calcium value more than 2.87 mmol/L
  • Baseline Ca x P of greater than 5.63 mmol2/l2
  • Positive for HBsAg or Hepatitis C with raised ALT twice above upper limit of normal or evidence of liver cirrhosis
  • Clinically significant gastrointestinal disease
  • History of allergic reaction to calcitriol or other vitamin D compounds
  • Inability or unwillingness to provide written consent.
  • Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.
  • Pregnancy, breastfeeding or use of non-reliable method of contraception.
  • Use of medications prohibited prior to randomization such as ketoconazole and other strong P450 3A inhibitors including atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir
  • Necessity for calcitonin, biphosphonates, maintenance oral or intravenous glucocorticoid or cinacalcet or other drugs that may affect calcium or bone metabolism.
  • Alcohol or substance abuse within 6 months prior to screening
  • Other medical condition which, in the investigator's judgement, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
  • Participation in another clinical trial and/or receipt of investigational drugs within 4 weeks prior to screening visit.
  • If PD subjects had active peritonitis within one month prior to the screening visit
  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: NCT00800358

Locations
Malaysia
Hospital Sultanah Bahiyah Haemodialysis Unit KM 6 Jalan Langgar
Alor Star, Kedah, Malaysia, 05460
Hemodialysis Unit, Raja Perempuan Zainab II Hospital
Kota Bahru, Kelantan, Malaysia, 15586
Hemodialysis Unit, Tengku Ampuan Afzan Hospital
Kuantan, Pahang, Malaysia, 25100
Clinical Research Centre, Penang Hospital
Georgetown, Penang, Malaysia, 10990
Haemodialysis Unit, Seberang Jaya Hospital
Seberang jaya, Penang, Malaysia, 13700
Hemodialysis Unit, Taiping Hospital
Taiping, Perak, Malaysia, 34000
Nephrology Department, Tengku Ampuan Rahimah Hospital
Klang, Selangor, Malaysia, 41200
Hemodialysis Unit, Kuala Lumpur Hospital
Kuala Lumpur, Selangor, Malaysia, 50586
Haemodialysis Unit, Serdang Hospital
Serdang, Selangor, Malaysia, 43000
Hemodialysis Unit, Tuanku Ja'afar Seremban Hospital
Seremban, Selangor, Malaysia, 70300
Haemodialysis Unit, Melaka Hospital
Melaka, Malaysia, 75400
Sponsors and Collaborators
Penang Hospital, Malaysia
Ministry of Health, Malaysia
Investigators
Principal Investigator: Ong L Meng, MBBS, MRCP Clinical Research Centre, Penang Hospital
  More Information

No publications provided by Penang Hospital, Malaysia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr.Ong Loke Meng, Consultant Nephrologist, Penang Hospital, Malaysia
ClinicalTrials.gov Identifier: NCT00800358     History of Changes
Other Study ID Numbers: Protocol No: CT 08-02
Study First Received: November 30, 2008
Last Updated: December 4, 2012
Health Authority: Malaysia : Medical Research Ethics Committee
Malaysia : Drug Control Authority (DCA)

Keywords provided by Penang Hospital, Malaysia:
Secondary hyperparathyroidism
End stage renal disease
Haemodialysis
Peritoneal dialysis
Paricalcitol (Zemplar)
Calcitriol

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Endocrine System Diseases
Parathyroid Diseases
Urologic Diseases
Calcitriol
Bone Density Conservation Agents
Calcium Channel Agonists
Cardiovascular Agents
Growth Substances
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents
Vitamins

ClinicalTrials.gov processed this record on October 23, 2014