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

NCT ID: NCT00800358

Last Updated: 2012-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-12-31

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.

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.

Conditions

Hyperparathyroidism; Kidney Disease

Keywords

Secondary hyperparathyroidism; End stage renal disease; Haemodialysis; Peritoneal dialysis; Paricalcitol (Zemplar); Calcitriol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Oral Paricalcitol in varying doses

Group Type: EXPERIMENTAL

Paricalitol

Intervention Type: DRUG

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

2

Calcitriol

Group Type: ACTIVE_COMPARATOR

Calcitriol

Intervention Type: DRUG

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

Interventions

Paricalitol

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

Intervention Type: DRUG

Calcitriol

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

Intervention Type: DRUG

Other Intervention Names

Zemplar

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role: collaborator

Penang Hospital, Malaysia

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr.Ong Loke Meng

Consultant Nephrologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ong L Meng, MBBS, MRCP

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Centre, Penang Hospital

Locations

Hospital Sultanah Bahiyah Haemodialysis Unit KM 6 Jalan Langgar

Alor Star, Kedah, Malaysia

Hemodialysis Unit, Raja Perempuan Zainab II Hospital

Kota Bharu, Kelantan, Malaysia

Haemodialysis Unit, Melaka Hospital

Malacca, Melaka, Malaysia

Hemodialysis Unit, Tengku Ampuan Afzan Hospital

Kuantan, Pahang, Malaysia

Hemodialysis Unit, Taiping Hospital

Taiping, Perak, Malaysia

Clinical Research Centre, Penang Hospital

George Town, Pulau Pinang, Malaysia

Haemodialysis Unit, Seberang Jaya Hospital

Seberang Jaya, Pulau Pinang, Malaysia

Nephrology Department, Tengku Ampuan Rahimah Hospital

Klang, Selangor, Malaysia

Hemodialysis Unit, Kuala Lumpur Hospital

Kuala Lumpur, Selangor, Malaysia

Haemodialysis Unit, Serdang Hospital

Serdang, Selangor, Malaysia

Hemodialysis Unit, Tuanku Ja'afar Seremban Hospital

Seremban, Selangor, Malaysia

Countries

Malaysia

References

Ong LM, Narayanan P, Goh HK, Manocha AB, Ghazali A, Omar M, Mohamad S, Goh BL, Shah S, Seman MR, Vaithilingam I, Ghazalli R, Rahmat K, Shaariah W, Ching CH; Oral Paricalcitol in ESRD Study Group. Randomized controlled trial to compare the efficacy and safety of oral paricalcitol with oral calcitriol in dialysis patients with secondary hyperparathyroidism. Nephrology (Carlton). 2013 Mar;18(3):194-200. doi: 10.1111/nep.12029.

Reference Type: DERIVED

PMID: 23311404 (View on PubMed)

Other Identifiers

Protocol No: CT 08-02

Identifier Type: -

Identifier Source: org_study_id