Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation
Prospective, Open-label, Multicenter Effectiveness and Safety Observational Study of Zemplar in Patients With Stage 5 Chronic Kidney Disease and Hyperparathyroidism on Hemodialysis in the Russian Federation
調査の概要
状態
条件
詳細な説明
Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Study drug will be administered per local prescribing guidelines. Planned therapy is six months. Intact Parathyroid Hormone will be measured at the Screening visit. All participants who meet the inclusion criteria and fail to meet the exclusion criteria will be included in the study.
Adverse events will be monitored throughout the observation period (and up to 30 days after the last dose of Zemplar).
Ability of Zemplar to lower intact Parathyroid Hormone level will be assessed throughout the study. Proportion of participants with the level of intact Parathyroid Hormone 150 - 300 pg/mL was stated as primary endpoint. Calcium and Phosphorus elevation will be also measured throughout the study.
The selected population is representative in relation to those who will take Zemplar in routine practice. Participants with contraindications to Zemplar therapy (as per the local label) will not be included in the study.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Almetyevsk、ロシア連邦、423450
- Site Reference ID/Investigator# 57348
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Cheboksary、ロシア連邦、428018
- Site Reference ID/Investigator# 57347
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Chelyabinsk、ロシア連邦、454076
- Site Reference ID/Investigator# 58347
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Iakutsk、ロシア連邦、677019
- Site Reference ID/Investigator# 67404
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Irkutsk、ロシア連邦、664079 RF
- Site Reference ID/Investigator# 57344
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Kazan、ロシア連邦、420045
- Site Reference ID/Investigator# 57346
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Moscow、ロシア連邦、125284
- Site Reference ID/Investigator# 58356
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Moscow、ロシア連邦、127015
- Site Reference ID/Investigator# 58348
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Novosibirsk、ロシア連邦、630120
- Site Reference ID/Investigator# 57342
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Orenburg、ロシア連邦、460040
- Site Reference ID/Investigator# 57364
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Samara、ロシア連邦、443095
- Site Reference ID/Investigator# 69687
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St. Petersburg、ロシア連邦、191104
- Site Reference ID/Investigator# 57363
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Ulan-Ude、ロシア連邦、670031
- Site Reference ID/Investigator# 69688
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age 18-65 years
- Chronic Kidney Disease stage 5 receiving hemodialysis
- Authorization (Consent) for Use/Disclosure of Data signed by the patient
- Planned prescription of Zemplar treatment due to fair clinical need and irrespectively of the participation in the current program according to the local label within 2 weeks after screening into the program
- Screening intact Parathyroid Hormone level (measured not earlier than 1 month before first dose of Zemplar) between 300 and 900 pg/mL
Exclusion Criteria:
- Contraindications to Zemplar as indicated in approved label, including but not limited to hypersensitivity, hypervitaminosis D (serum D3 level above 32 ng/mL), concomitant use of vitamin D or phosphates, lactation period, pregnancy
- Any experimental drug within the period of 30 days before the inclusion into the program
- Screening Ca x P > 65 mg˄2/dL˄2
- Screening normalized serum total calcium > 10.2 mg/dL
- Necessity for calcitonin maintenance oral or intravenous glucocorticoids, or other drugs that could have affected calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy
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
コホートと介入
グループ/コホート |
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Stage 5 Chronic Kidney Disease
Planned for Zemplar administration due to secondary hyperparathyroidism
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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 |
メジャーの説明 |
時間枠 |
---|---|---|
The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study
時間枠:6 months
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The percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded.
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study
時間枠:6 months
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The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as achievement of iPTH level 2 to 9 times the upper limit of normal) at least once during the study was recorded.
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6 months
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Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study
時間枠:6 months
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The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as the achievement of iPTH level 2 to 9 times the upper limit of normal) at each visit during the study was recorded.
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6 months
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Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Least Once Post-baseline During the Study
時間枠:6 months
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The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at least once post-baseline during the study was recorded.
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6 months
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Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study
時間枠:6 months
|
The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at each visit post-baseline during the study was recorded.
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6 months
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Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study
時間枠:6 months
|
The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at least once post-baseline during the study was recorded.
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6 months
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Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study
時間枠:6 months
|
The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at each visit post-baseline during the study was recorded.
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6 months
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Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination
時間枠:6 months
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The percentage of participants who developed hypercalcemia (too much calcium in the blood) and hyperphosphatemia (too much phosphate in the blood) leading to study termination was recorded. Hypercalcemia was defined as calcium level greater than 11.2 mg/dL for more than 8 weeks, and hyperphosphatemia was defined as phosphate level greater than 6.5 mg/dL for more than 8 weeks. |
6 months
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協力者と研究者
協力者
捜査官
- スタディディレクター:Andrey Strugovshchikov, MD、AbbVie LLC
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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
本研究に関する用語
キーワード
その他の研究ID番号
- P12-838
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