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

Primary Purpose

Hyperparathyroidism, Kidney Disease

Status

Completed

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

Paricalitol

Calcitriol

About this trial

This is an interventional treatment trial for Hyperparathyroidism focused on measuring Secondary hyperparathyroidism, End stage renal disease, Haemodialysis, Peritoneal dialysis, Paricalcitol (Zemplar), Calcitriol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Sultanah Bahiyah Haemodialysis Unit KM 6 Jalan Langgar
Hemodialysis Unit, Raja Perempuan Zainab II Hospital
Hemodialysis Unit, Tengku Ampuan Afzan Hospital
Clinical Research Centre, Penang Hospital
Haemodialysis Unit, Seberang Jaya Hospital
Hemodialysis Unit, Taiping Hospital
Nephrology Department, Tengku Ampuan Rahimah Hospital
Hemodialysis Unit, Kuala Lumpur Hospital
Haemodialysis Unit, Serdang Hospital
Hemodialysis Unit, Tuanku Ja'afar Seremban Hospital
Haemodialysis Unit, Melaka Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Oral Paricalcitol in varying doses

Calcitriol

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Incidence of hypercalcaemic episodes

Full Information

NCT ID

NCT00800358

First Posted

November 30, 2008

Last Updated

December 4, 2012

Sponsor

Penang Hospital, Malaysia

Collaborators

Ministry of Health, Malaysia

1. Study Identification

Unique Protocol Identification Number

NCT00800358

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Penang Hospital, Malaysia

Collaborators

Ministry of Health, Malaysia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperparathyroidism, Kidney Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Oral Paricalcitol in varying doses

Arm Title

Arm Type

Active Comparator

Arm Description

Calcitriol

Intervention Type

Drug

Intervention Name(s)

Paricalitol

Other Intervention Name(s)

Zemplar

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Calcitriol

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

24 weeks

Title

Incidence of hypercalcaemic episodes

Time Frame

Through out 24 weeks of participation from the time of enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ong L Meng, MBBS, MRCP

Organizational Affiliation

Clinical Research Centre, Penang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Sultanah Bahiyah Haemodialysis Unit KM 6 Jalan Langgar

City

Alor Star

State/Province

Kedah

ZIP/Postal Code

05460

Country

Malaysia

Facility Name

Hemodialysis Unit, Raja Perempuan Zainab II Hospital

City

Kota Bahru

State/Province

Kelantan

ZIP/Postal Code

15586

Country

Malaysia

Facility Name

Hemodialysis Unit, Tengku Ampuan Afzan Hospital

City

Kuantan

State/Province

Pahang

ZIP/Postal Code

25100

Country

Malaysia

Facility Name

Clinical Research Centre, Penang Hospital

City

Georgetown

State/Province

Penang

ZIP/Postal Code

10990

Country

Malaysia

Facility Name

Haemodialysis Unit, Seberang Jaya Hospital

City

Seberang jaya

State/Province

Penang

ZIP/Postal Code

13700

Country

Malaysia

Facility Name

Hemodialysis Unit, Taiping Hospital

City

Taiping

State/Province

Perak

ZIP/Postal Code

34000

Country

Malaysia

Facility Name

Nephrology Department, Tengku Ampuan Rahimah Hospital

City

Klang

State/Province

Selangor

ZIP/Postal Code

41200

Country

Malaysia

Facility Name

Hemodialysis Unit, Kuala Lumpur Hospital

City

Kuala Lumpur

State/Province

Selangor

ZIP/Postal Code

50586

Country

Malaysia

Facility Name

Haemodialysis Unit, Serdang Hospital

City

Serdang

State/Province

Selangor

ZIP/Postal Code

43000

Country

Malaysia

Facility Name

Hemodialysis Unit, Tuanku Ja'afar Seremban Hospital

City

Seremban

State/Province

Selangor

ZIP/Postal Code

70300

Country

Malaysia

Facility Name

Haemodialysis Unit, Melaka Hospital

City

Melaka

ZIP/Postal Code

75400

Country

Malaysia

12. IPD Sharing Statement

Citations:

PubMed Identifier

23311404

Citation

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.

Results Reference

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

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