Status:
COMPLETED
Safety and Efficacy Study of Paricalcitol Versus Calcitriol in the Treatment of Secondary Hyperparathyroidism
Lead Sponsor:
Penang Hospital, Malaysia
Collaborating Sponsors:
Ministry of Health, Malaysia
Conditions:
Hyperparathyroidism
Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00800358
Start Date
November 1 2008
End Date
December 1 2009
Last Update
December 6 2012
Active Locations (11)
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1
Hospital Sultanah Bahiyah Haemodialysis Unit KM 6 Jalan Langgar
Alor Star, Kedah, Malaysia, 05460
2
Hemodialysis Unit, Raja Perempuan Zainab II Hospital
Kota Bharu, Kelantan, Malaysia, 15586
3
Haemodialysis Unit, Melaka Hospital
Malacca, Melaka, Malaysia, 75400
4
Hemodialysis Unit, Tengku Ampuan Afzan Hospital
Kuantan, Pahang, Malaysia, 25100