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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00800358
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : December 6, 2012
Ministry of Health, Malaysia
Information provided by (Responsible Party):
Dr.Ong Loke Meng, Penang Hospital, Malaysia

Brief Summary:
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 or disease Intervention/treatment Phase
Hyperparathyroidism Kidney Disease Drug: Paricalitol Drug: Calcitriol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Drug: Calcitriol
oral calcitriol variable daily dosing based on intact PTH level for 6 months

Primary Outcome Measures :
  1. More than 30% reduction in baseline iPTH concentration at 24 weeks of treatment with Paricalcitol or Calcitriol capsules. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. Incidence of hypercalcaemic episodes [ Time Frame: Through out 24 weeks of participation from the time of enrollment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00800358

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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
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Principal Investigator: Ong L Meng, MBBS, MRCP Clinical Research Centre, Penang Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr.Ong Loke Meng, Consultant Nephrologist, Penang Hospital, Malaysia Identifier: NCT00800358     History of Changes
Other Study ID Numbers: Protocol No: CT 08-02
First Posted: December 2, 2008    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012
Keywords provided by Dr.Ong Loke Meng, Penang Hospital, Malaysia:
Secondary hyperparathyroidism
End stage renal disease
Peritoneal dialysis
Paricalcitol (Zemplar)
Additional relevant MeSH terms:
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Kidney Diseases
Hyperparathyroidism, Secondary
Urologic Diseases
Parathyroid Diseases
Endocrine System Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents