Safety and Efficacy Study of Paricalcitol Versus Calcitriol in the Treatment of Secondary Hyperparathyroidism
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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 |
- 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 ]
- 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 |
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| 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 | |
| Principal Investigator: | Ong L Meng, MBBS, MRCP | Clinical Research Centre, Penang Hospital |
More Information
No publications provided
| 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 Parathyroid Diseases Endocrine System Diseases Urologic Diseases Calcitriol Ergocalciferols Vitamins Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013