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Safety and Efficacy Study of Paricalcitol Versus Calcitriol in the Treatment of Secondary Hyperparathyroidism in Dialysis Patients
This study is not yet open for participant recruitment.
Verified by Penang Hospital, Malaysia, November 2008
Sponsors and Collaborators: Penang Hospital, Malaysia
Ministry of Health, Malaysia
Information provided by: Penang Hospital, Malaysia
ClinicalTrials.gov Identifier: NCT00800358
  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

MedlinePlus related topics: Dialysis Kidney Failure
Drug Information available for: Calcitriol 19-Nor-1alpha,25-dihydroxyvitamin D2
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 Chronic Kidney Disease Patients Undergoing Dialysis.

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 ]

Estimated Enrollment: 60
Study Start Date: November 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Paricalcitol
Drug: Paricalitol
oral paricalcitol variable daily dosing based on intact PTH level for 6 months
2: Active Comparator
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800358

Contacts
Contact: Malinee Neelamegam 00 604 2225762 malinee@crc.gov.my
Contact: Salawati Saedin 00 604 2225765 salawati@crc.gov.my

Locations
Malaysia
Haemodialysis Unit, Melaka Hospital
Melaka, Malaysia, 75400
Malaysia, Kelantan
Hemodialysis Unit, Raja Perempuan Zainab II Hospital
Kota Bahru, Kelantan, Malaysia, 15586
Malaysia, Pahang
Hemodialysis Unit, Tengku Ampuan Afzan Hospital
Kuantan, Pahang, Malaysia, 25100
Malaysia, Penang
Clinical Research Centre, Penang Hospital
Georgetown, Penang, Malaysia, 10990
Haemodialysis Unit, Seberang Jaya Hospital
Seberang jaya, Penang, Malaysia, 13700
Malaysia, Perak
Hemodialysis Unit, Taiping Hospital
Taiping, Perak, Malaysia, 34000
Haemodialysis Unit, Ipoh Hospital
Ipoh, Perak, Malaysia, 30990
Malaysia, Perlis
Haemodialysis Unit, Sultanah Bahiyah Hospital
Alor Setar, Perlis, Malaysia, 05460
Malaysia, Selangor
Hemodialysis Unit, Kuala Lumpur Hospital
Kuala Lumpur, Selangor, Malaysia, 50586
Haemodialysis Unit, Serdang Hospital
Serdang, Selangor, Malaysia, 43000
Nephrology Department, Tengku Ampuan Rahimah Hospital
Klang, Selangor, Malaysia, 41200
Hemodialysis Unit, Tuanku Ja'afar Seremban Hospital
Seremban, Selangor, Malaysia, 70300
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

Responsible Party: Penang Hospital, Ministry of Health, Malaysia ( Dr. Ong Loke Meng, Consultant Nephrologist )
Study ID Numbers: Protocol No: CT 08-02
Study First Received: November 30, 2008
Last Updated: December 1, 2008
ClinicalTrials.gov Identifier: NCT00800358  
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
Secondary hyperparathyroidism in chronic kidney disease patients undergoing dialysis.

Study placed in the following topic categories:
Parathyroid Diseases
Renal Insufficiency
Kidney Failure, Chronic
Endocrine System Diseases
Calcitriol
Calcium, Dietary
Hyperparathyroidism, Secondary
Hyperparathyroidism
Urologic Diseases
Renal Insufficiency, Chronic
Neoplasm Metastasis
Kidney Diseases
Endocrinopathy
Kidney Failure

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Calcium Channel Agonists
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators
Neoplastic Processes
Neoplasms
Pathologic Processes
Therapeutic Uses
Vitamins
Vasoconstrictor Agents
Micronutrients

ClinicalTrials.gov processed this record on February 12, 2009