Kidney Disease Clinical Trial
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
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.
Status | Completed |
Enrollment | 69 |
Est. completion date | December 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Malaysia | Hospital Sultanah Bahiyah Haemodialysis Unit KM 6 Jalan Langgar | Alor Star | Kedah |
Malaysia | Clinical Research Centre, Penang Hospital | Georgetown | Penang |
Malaysia | Nephrology Department, Tengku Ampuan Rahimah Hospital | Klang | Selangor |
Malaysia | Hemodialysis Unit, Raja Perempuan Zainab II Hospital | Kota Bahru | Kelantan |
Malaysia | Hemodialysis Unit, Kuala Lumpur Hospital | Kuala Lumpur | Selangor |
Malaysia | Hemodialysis Unit, Tengku Ampuan Afzan Hospital | Kuantan | Pahang |
Malaysia | Haemodialysis Unit, Melaka Hospital | Melaka | |
Malaysia | Haemodialysis Unit, Seberang Jaya Hospital | Seberang jaya | Penang |
Malaysia | Haemodialysis Unit, Serdang Hospital | Serdang | Selangor |
Malaysia | Hemodialysis Unit, Tuanku Ja'afar Seremban Hospital | Seremban | Selangor |
Malaysia | Hemodialysis Unit, Taiping Hospital | Taiping | Perak |
Lead Sponsor | Collaborator |
---|---|
Penang Hospital, Malaysia | Ministry of Health, Malaysia |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | More than 30% reduction in baseline iPTH concentration at 24 weeks of treatment with Paricalcitol or Calcitriol capsules. | 24 weeks | No | |
Secondary | 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 | No | |
Secondary | Incidence of hypercalcaemic episodes | Through out 24 weeks of participation from the time of enrollment | Yes |
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