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
2013년 1월 11일 업데이트: 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.
연구 개요
상태
완전한
정황
상세 설명
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.
연구 유형
관찰
등록 (실제)
60
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Budapest, 헝가리, 1083
- Site Reference ID/Investigator# 46593
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Budapest, 헝가리, 1115
- Site Reference ID/Investigator# 46585
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Debrecen, 헝가리, 4012
- Site Reference ID/Investigator# 46594
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Gyor, 헝가리, 9023
- Site Reference ID/Investigator# 47722
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Karcag, 헝가리, 5301
- Site Reference ID/Investigator# 46592
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Karcag, 헝가리, 5301
- Site Reference ID/Investigator# 58644
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Miskolc, 헝가리, 3501
- Site Reference ID/Investigator# 46595
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Nyiregyhaza, 헝가리, 4400
- Site Reference ID/Investigator# 46588
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Pecs, 헝가리, 7624
- Site Reference ID/Investigator# 46597
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Szombathely, 헝가리, 9700
- Site Reference ID/Investigator# 46590
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Veszprem, 헝가리, 8200
- Site Reference ID/Investigator# 46591
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Stage 5 chronic kidney disease patients treated in haemodialysis centers in Hungary
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 연구 책임자: Tamas Schnaider, AbbVie (prior sponsor, Abbott)
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 1월 1일
기본 완료 (실제)
2011년 11월 1일
연구 완료 (실제)
2011년 11월 1일
연구 등록 날짜
최초 제출
2010년 11월 22일
QC 기준을 충족하는 최초 제출
2011년 1월 7일
처음 게시됨 (추정)
2011년 1월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 1월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 1월 11일
마지막으로 확인됨
2013년 1월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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