Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Zemplar® (Paricalcitol Injection) in the Treatment of Patients Suffering From End-stage Renal Disease and Severe Over-reactivity of the Parathyroid Glands
2013年1月11日 更新者：AbbVie (prior sponsor, Abbott)
Post-marketing Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Paricalcitol i.v. in the Treatment of Chronic Kidney Disease (CKD) 5 Stage Patients With (Severe) Secondary Hyperparathyroidism in Hungary
This observational study will evaluate the clinical benefit of Zemplar (paricalcitol injection) in daily routine practice in end-stage renal disease patients with severe over-reactivity of parathyroid glands.
Participants will be followed for 6 months.
Data will be collected from participants initiated on Zemplar therapy according to standard of care.
The time to achieving the maintenance dose of Zemplar (paricalcitol injection), the proportion of participants achieving target parathyroid hormone levels, and prevalence of elevated serum calcium and phosphate levels will be evaluated.
調査の概要
状態
完了
条件
詳細な説明
Prospective data collection started at initial dosing with Zemplar (paricalcitol injection) and ended up to 6 months later.
If available, retrospective data on vitamin D treatment as well as on the incidence of hypercalcaemia and hyperphosphataemia in the 6 months leading up to paricalcitol treatment were also collected.
Eight visits were planned for documentation of prospective data.
In accordance with the non-interventional character of the study, only diagnostic and monitoring procedures were applied which are part of the routine medical care of secondary hyperparathyroidism.
研究の種類
観察的
入学 (実際)
60
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Budapest、ハンガリー、1083
- Site Reference ID/Investigator# 46593
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Budapest、ハンガリー、1115
- Site Reference ID/Investigator# 46585
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Debrecen、ハンガリー、4012
- Site Reference ID/Investigator# 46594
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Gyor、ハンガリー、9023
- Site Reference ID/Investigator# 47722
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Karcag、ハンガリー、5301
- Site Reference ID/Investigator# 46592
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Karcag、ハンガリー、5301
- Site Reference ID/Investigator# 58644
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Miskolc、ハンガリー、3501
- Site Reference ID/Investigator# 46595
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Nyiregyhaza、ハンガリー、4400
- Site Reference ID/Investigator# 46588
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Pecs、ハンガリー、7624
- Site Reference ID/Investigator# 46597
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Szombathely、ハンガリー、9700
- Site Reference ID/Investigator# 46590
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Veszprem、ハンガリー、8200
- Site Reference ID/Investigator# 46591
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Stage 5 chronic kidney disease patients treated in haemodialysis centers in Hungary
説明
Inclusion Criteria:
Based on the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection), the patient is entitled to treatment with paricalcitol injection and:
- ≥ 18 years of age,
- Willing to sign the patient information and informed consent form,
Chronic kidney disease (CKD) stage 5 patient receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT), whose intact parathyroid hormone (iPTH) level is:
- between 500-800 pg/mL with at least two abruption of conventional vitamin D therapy due to elevated serum calcium level (i.e. > 2.4 mmol/L) in the medical history, or
- higher than 800 pg/mL and parathyroidectomy is contraindicated.
- The patient is planned to receive paricalcitol treatment independently from his/her participation in this study.
Exclusion Criteria:
Patients cannot be enrolled in the study if any of the following exclusion criteria apply:
- The patient is already treated with Zemplar (paricalcitol injection),
- Any contraindication exists as stated in the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection),
- Patients who decline to participate in the study or decline to sign the patient information/informed consent form.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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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End-stage kidney disease with secondary hyperparathyroidism
Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
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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 |
|---|---|---|
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Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)
時間枠：6 months
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Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.
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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 |
|---|---|---|
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Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6
時間枠：6 months
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Target intact parathyroid hormone (iPTH) values were within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.
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6 months
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Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance
時間枠：6 months prior to start of study through 6 months of treatment
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If available, data on vitamin D treatment (those who received vitamin D supplement products from Anatomical Therapeutic Chemical [ATC] group A11CC [vitamin D and analogues]) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
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6 months prior to start of study through 6 months of treatment
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Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance
時間枠：6 months prior to start of study through 6 months of treatment
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If available, data on the use of phosphate binders (those who received calcium-based phosphate binders or sevelamer/lanthanum) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
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6 months prior to start of study through 6 months of treatment
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Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism
時間枠：6 months prior to start of study through 6 months of treatment
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If available, data on the use of medication affecting secondary hyperparathyroidism (those who received calcimimetics and calcium supplementation) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.
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6 months prior to start of study through 6 months of treatment
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Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy
時間枠：6 months prior to start of study through baseline
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Hypercalcaemia (serum calcium > 2.6 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline.
Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).
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6 months prior to start of study through baseline
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Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
時間枠：6 months
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Hypercalcaemia (serum calcium > 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
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6 months
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Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy
時間枠：6 months prior to start of study through baseline
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Hyperphosphataemia (serum phosphorus >1.78 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline.
Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).
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6 months prior to start of study through baseline
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Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment
時間枠：6 months
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Hyperphosphataemia (serum phosphorus > 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).
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6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- スタディディレクター：Tamas Schnaider、AbbVie (prior sponsor, Abbott)
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年1月1日
一次修了 (実際)
2011年11月1日
研究の完了 (実際)
2011年11月1日
試験登録日
最初に提出
2010年11月22日
QC基準を満たした最初の提出物
2011年1月7日
最初の投稿 (見積もり)
2011年1月10日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年1月18日
QC基準を満たした最後の更新が送信されました
2013年1月11日
最終確認日
2013年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。