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

NCT00800358 | Completed DMC

• 1 other identifier: Protocol No: CT 08-02
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 11

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.

Conditions

Hyperparathyroidism; Kidney Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

Oral Paricalcitol in varying doses

Drug: Paricalitol

2

ACTIVE COMPARATOR

Calcitriol

Drug: Calcitriol

Interventions

Paricalitol DRUG

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

Also known as: Zemplar

1

Calcitriol DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penang Hospital, Malaysia: lead
• Ministry of Health, Malaysia: collaborator

Study Sites (11)

Hospital Sultanah Bahiyah Haemodialysis Unit KM 6 Jalan Langgar

Alor Star, Kedah, 05460, Malaysia

Location

Hemodialysis Unit, Raja Perempuan Zainab II Hospital

Kota Bharu, Kelantan, 15586, Malaysia

Location

Haemodialysis Unit, Melaka Hospital

Malacca, Melaka, 75400, Malaysia

Location

Hemodialysis Unit, Tengku Ampuan Afzan Hospital

Kuantan, Pahang, 25100, Malaysia

Location

Hemodialysis Unit, Taiping Hospital

Taiping, Perak, 34000, Malaysia

Location

Clinical Research Centre, Penang Hospital

George Town, Pulau Pinang, 10990, Malaysia

Location

Haemodialysis Unit, Seberang Jaya Hospital

Seberang Jaya, Pulau Pinang, 13700, Malaysia

Location

Nephrology Department, Tengku Ampuan Rahimah Hospital

Klang, Selangor, 41200, Malaysia

Location

Hemodialysis Unit, Kuala Lumpur Hospital

Kuala Lumpur, Selangor, 50586, Malaysia

Location

Haemodialysis Unit, Serdang Hospital

Serdang, Selangor, 43000, Malaysia

Location

Hemodialysis Unit, Tuanku Ja'afar Seremban Hospital

Seremban, Selangor, 70300, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 23311404 DERIVED

MeSH Terms

Conditions

Hyperparathyroidism; Kidney Diseases; Hyperparathyroidism, Secondary; Kidney Failure, Chronic

Interventions

paricalcitol; Calcitriol

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Ong L Meng, MBBS, MRCP

  Clinical Research Centre, Penang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Nephrologist

Study Record Dates

• First Submitted: November 30, 2008
• First Posted: December 2, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

MY (11)