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| Name | Class |
|---|---|
| Ministry of Health, Malaysia | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Oral Paricalcitol in varying doses |
|
| 2 | Active Comparator | Calcitriol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paricalitol | Drug | oral paricalcitol variable daily dosing based on intact PTH level for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| More than 30% reduction in baseline iPTH concentration at 24 weeks of treatment with Paricalcitol or Calcitriol capsules. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ong L Meng, MBBS, MRCP | Clinical Research Centre, Penang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sultanah Bahiyah Haemodialysis Unit KM 6 Jalan Langgar | Alor Star | Kedah | 05460 | Malaysia | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23311404 | Derived | 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. |
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| Calcitriol | Drug | oral calcitriol variable daily dosing based on intact PTH level for 6 months |
|
| Hemodialysis Unit, Raja Perempuan Zainab II Hospital |
| Kota Bharu |
| Kelantan |
| 15586 |
| Malaysia |
| Haemodialysis Unit, Melaka Hospital | Malacca | Melaka | 75400 | Malaysia |
| Hemodialysis Unit, Tengku Ampuan Afzan Hospital | Kuantan | Pahang | 25100 | Malaysia |
| Hemodialysis Unit, Taiping Hospital | Taiping | Perak | 34000 | Malaysia |
| Clinical Research Centre, Penang Hospital | George Town | Pulau Pinang | 10990 | Malaysia |
| Haemodialysis Unit, Seberang Jaya Hospital | Seberang Jaya | Pulau Pinang | 13700 | Malaysia |
| Nephrology Department, Tengku Ampuan Rahimah Hospital | Klang | Selangor | 41200 | Malaysia |
| Hemodialysis Unit, Kuala Lumpur Hospital | Kuala Lumpur | Selangor | 50586 | Malaysia |
| Haemodialysis Unit, Serdang Hospital | Serdang | Selangor | 43000 | Malaysia |
| Hemodialysis Unit, Tuanku Ja'afar Seremban Hospital | Seremban | Selangor | 70300 | Malaysia |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D007674 | Kidney Diseases |
| D006962 | Hyperparathyroidism, Secondary |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C084656 | paricalcitol |
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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