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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Penang Hospital, Malaysia
• Collaborator: Ministry of Health, Malaysia
• Treatments: Calcitriol; Ergocalciferols

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