Cinacalcet in Management of Secondary Hyperparathyroidism in Haemodialysis Patients
An Open-label Study of Combination of Cinacalcet and Active Vitamin D Analogue in the Management of Severe Secondary Hyperparathyroidism in Haemodialysis Patients
This is a single arm, open-labelled study to determine the effectiveness of combination Cinacalcet with Vitamin D analogue in the treatment of severe hyperparathyroidism in patients with ESRF on haemodialysis. Patients will be started on PO Cinacalcet 25mg OD + PO/IV active Vitamin D analogues adjusted by increments/decrements in steps of 1 mcg 3x per week every 1-4 weeks until the corrected calcium level is within 2.4-2.54 mmol/L. After iPTH has reached 2-9x ULN, patient enters maintenance phase. If serum calcium falls below 2.1mmol/L, active Vit D dose will be increased and if it is above 2.54 mmol/L, the dose will be decreased.
Percentage reduction of iPTH levels from baseline at 6,12 and 24 months treatment and Percentage of patients achieving iPTH levels within the target range of 2-9x upper limit normal at 6, 12 and 24 months will be determined
調査の概要
詳細な説明
Many patients on haemodialysis will develop secondary hyperparathyroidism. Vitamin D analogues such as alphacalcidol are needed to bring their iPTH levels down to normal. However, these analogues can cause hypercalcaemia, thus its doses are limited by this effect. Cinacalcet, which is currently not widely available to patients in hospitals, is a calcimimetic that can reduce both iPTH and serum calcium levels. No studies have yet to be carried out investigating the outcome of using low doses of Cinacalcet as a means of optimizing doses of vitamin D analogues by keeping calcium levels from going over the upper limit. So a single arm, open-labelled study has been designed to determine the effectiveness of combination Cinacalcet with Vitamin D analogue in the treatment of severe hyperparathyroidism in patients with ESRF on haemodialysis. No formal sample size calculation was done as this is a proof of concept study. Power calculation will be done at the end based on the primary outcome of the study.
Methodology: Patients will be started on PO Cinacalcet 25mg OD + PO/IV active Vitamin D analogues adjusted by increments/decrements in steps of 1 mcg 3x per week every 1-4 weeks until the corrected calcium level is within 2.4-2.54 mmol/L. After iPTH has reached 2-9x ULN, patient enters maintenance phase. If serum calcium falls below 2.1mmol/L, active Vit D dose will be increased and if it is above 2.54 mmol/L, the dose will be decreased.
Percentage reduction of iPTH levels from baseline at 6,12 and 24 months treatment and Percentage of patients achieving iPTH levels within the target range of 2-9x upper limit normal at 6, 12 and 24 months will be determined.
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
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Penang
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George Town、Penang、マレーシア、10990
- Penang Hospital
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George Town、Penang、マレーシア、10990
- Clinical Research Centre, Penang Hospital
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:1. End Stage Renal Failure (ESRF) patients on haemodialysis with iPTH levels more than 9x upper limit normal 2. Patients who has history of active Vitamin D analogue doses limited by hypercalcaemia (>2.54 mmol/L)
Exclusion Criteria:
- Pregnant or breastfeeding or planning to become pregnant
- Life expectancy of 6 months or less
- History of decompensated liver disease
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Cinacalcet with Vitamin D arm
Depending on the iPTH level and the serum calcium level they will be started on Cinacalcet 25mg OD and active Vitamin D will be adjusted.
If Serum Cal <2.4 mmol/L - Start Cinacalcet 25mg OD & Increase active Vit D by 1 mcg/dose 3x/week Increase active Vit D by 1 mcg/dose 3x/week or Serum Ca 2.4-2.54
mmol/L- Start Cinacalcet 25mg OD and Maintain active Vit D dose OR if >2.54 mmol/L - Start Cinacalcet 25mg OD & Maintain active Vit D dose.
Then they will go to maintenance phase.
|
Depending on the iPTH level and the serum calcium level they will be started on Cinacalcet 25mg OD and active Vitamin D will be adjusted.
If Serum Cal <2.4 mmol/L - Start Cinacalcet 25mg OD & Increase active Vit D by 1 mcg/dose 3x/week Increase active Vit D by 1 mcg/dose 3x/week or Serum Ca 2.4-2.54
mmol/L- Start Cinacalcet 25mg OD and Maintain active Vit D dose OR if >2.54 mmol/L - Start Cinacalcet 25mg OD & Maintain active Vit D dose.
Then they will go to maintenance phase.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Percentage reduction of iPTH levels from baseline at 6 months treatment
時間枠:6 months
|
6 months
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Percentage of patients achieving iPTH levels within the target range of 2-9x upper limit normal at 6, 12 and 24 months
時間枠:24 months
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24 months
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The maximum iPTH reduction from baseline
時間枠:24 months
|
24 months
|
協力者と研究者
捜査官
- 主任研究者:Ong Loke Meng, FRCS、Clinical Research Centre, Penang Hospital, Malaysia
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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