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

Sponsor

Penang Hospital, Malaysia (Other)

Overall Status

Completed

CT.gov ID

NCT00800358

Collaborator

Ministry of Health, Malaysia (Other)

Enrollment

Locations

Arms

Duration (Months)

6.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

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 :

Nov 1, 2008

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

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 Names: Zemplar
Active Comparator: 2 Calcitriol	Drug: Calcitriol oral calcitriol variable daily dosing based on intact PTH level for 6 months

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 Names:

Zemplar

Active Comparator: 2

Calcitriol

Drug: Calcitriol

oral calcitriol variable daily dosing based on intact PTH level for 6 months

Outcome Measures

Primary Outcome Measures

More than 30% reduction in baseline iPTH concentration at 24 weeks of treatment with Paricalcitol or Calcitriol capsules. [24 weeks]

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 [24 weeks]
Incidence of hypercalcaemic episodes [Through out 24 weeks of participation from the time of enrollment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital Sultanah Bahiyah Haemodialysis Unit KM 6 Jalan Langgar	Alor Star	Kedah	Malaysia	05460
2	Hemodialysis Unit, Raja Perempuan Zainab II Hospital	Kota Bahru	Kelantan	Malaysia	15586
3	Hemodialysis Unit, Tengku Ampuan Afzan Hospital	Kuantan	Pahang	Malaysia	25100
4	Clinical Research Centre, Penang Hospital	Georgetown	Penang	Malaysia	10990
5	Haemodialysis Unit, Seberang Jaya Hospital	Seberang jaya	Penang	Malaysia	13700
6	Hemodialysis Unit, Taiping Hospital	Taiping	Perak	Malaysia	34000
7	Nephrology Department, Tengku Ampuan Rahimah Hospital	Klang	Selangor	Malaysia	41200
8	Hemodialysis Unit, Kuala Lumpur Hospital	Kuala Lumpur	Selangor	Malaysia	50586
9	Haemodialysis Unit, Serdang Hospital	Serdang	Selangor	Malaysia	43000
10	Hemodialysis Unit, Tuanku Ja'afar Seremban Hospital	Seremban	Selangor	Malaysia	70300
11	Haemodialysis Unit, Melaka Hospital	Melaka		Malaysia	75400