The Effect of Walking in Kidney Transplant Patients
2021年8月6日 更新者：FATMA DEMIR KORKMAZ、Ege University
The Effect of Pedometer Assisted Walking on Physical Activity Level and Metabolic Parameters in Patients With Renal Transplantation
Cardiovascular diseases are among the most common causes of death in kidney transplant patients.
Physical activity is of great importance in preventing cardiovascular diseases after transplantation.
Although regular physical activity is recommended in international guidelines to prevent post-transplant mortality and morbidity in kidney transplant patients, studies have shown that patients do not follow regular physical activity instructions.The aim of our project is to examine the effect of pedometer-assisted physical activity on metabolic parameters after kidney transplantation.
調査の概要
詳細な説明
Patients with kidney transplant surgery will be randomized to the intervention (n: 34) and control groups (n: 34), respectively, according to the transplant surgery date.
Intervention and Control groups will be given the same training on the importance of physical activity during discharge training.
The pedometer will be given to the intervention group to evaluate the activity level, and it will be said that their goal is to take 2000 steps in 20 minutes a day after discharge.
Patients will be asked to carry the pedometer during physical activity, and to write down the number of steps they take in 20 minutes on the form given to them for 90 days.
Patients in the control group will only be advised to do physical activity every day and will be asked to record the minutes of physical activity they do for 90 days.
Metabolic parameters of the patients in the intervention and control groups will be examined at the end of the 4th and 12th months.
These parameters are blood pressure, body mass index, complete blood count (hemoglobin, leukocyte, thrombocyte), blood glucose, sodium, potassium, calcium, liver enzymes, serum creatinine, total and indirect bilirubin, albumin and total cholesterol levels.
研究の種類
介入
入学 (予想される)
68
段階
- 適用できない
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。
研究連絡先
- 名前：Fatma DEMIR KORKMAZ, Professor
- 電話番号：+902323115506
- メール：fatma.demir@ege.edu.tr
研究連絡先のバックアップ
- 名前：Tugba Nur ODEN, PhD Student
- 電話番号：+902323905106
- メール：tugba.nur.zoturk@ege.edu.tr
研究場所
-
-
-
Izmir、七面鳥、35040
- 募集
- Ege university
-
コンタクト：
- Fatma DEMIR KORKMAZ, Professor
- 電話番号：+902323115506
- メール：fatma.demir@ege.edu.tr
-
コンタクト：
- Tugba Nur ODEN, PhD Student
- 電話番号：+902323905106
- メール：tugba.nur.ozturk@ege.edu.tr
-
-
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～65年 (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
説明
Inclusion Criteria: • Over the age of 18 and under the age of 65,
- Kidney transplantation at the center where the study was conducted between the research dates,
- There is no activity restriction recommendation by the physician,
- Patients who agree to participate in the study.
Exclusion Criteria:
- Multiple organ transplantation at the same time,
- Death or graft loss/rejection in the hospital before discharge,
- Patients with physical activity restrictions by the physician,
- Patients who are re-hospitalized within the first 3 months after discharge
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
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
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実験的：Using a pedometer
The pedometer will be given to the intervention group to evaluate the activity level and to encourage a walk , it will be said that their goal is to take 2000 steps in 20 minutes a day after discharge.
Patients will be asked to carry the pedometer during physical activity, and to write down the number of steps they take in 20 minutes on the form given to them for 90 days.
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2000 steps per day in 20 minutes for 90 days, guided by a pedometer after a kidney transplantation
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介入なし：Not using a pedometer
The control group will not be given a pedometer.Patients in the control group will only be instructed to do physical activity every day and will be asked to record the minutes of physical activity they do for 90 days.
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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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Blood Pressure
時間枠：Change from Baseline Blood Pressure at 4 months after discharge
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mmHg
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Change from Baseline Blood Pressure at 4 months after discharge
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Blood Pressure
時間枠：Change from Baseline Blood Pressure at 12 months after discharge
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mmHg
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Change from Baseline Blood Pressure at 12 months after discharge
|
|
Body Mass Index (BMI)
時間枠：Change from Baseline BMI at 4 months after discharge
|
BMI is weight in kilograms divided by height in meters squared.
Formula: weight (kg) / [height (m)]2
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Change from Baseline BMI at 4 months after discharge
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Body Mass Index (BMI)
時間枠：Change from Baseline BMI at 12 months after discharge
|
BMI is weight in kilograms divided by height in meters squared.
Formula: weight (kg) / [height (m)]2
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Change from Baseline BMI at 12 months after discharge
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Hemoglobin
時間枠：Change from Baseline Hemoglobin at 4 months after discharge
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g/dL
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Change from Baseline Hemoglobin at 4 months after discharge
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Hemoglobin
時間枠：Change from Baseline Hemoglobin at 12 months after discharge
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g/dL
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Change from Baseline Hemoglobin at 12 months after discharge
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Leukocyte
時間枠：Change from Baseline Leukocyte at 4 months after discharge
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10^3/µL
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Change from Baseline Leukocyte at 4 months after discharge
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Leukocyte
時間枠：Change from Baseline Leukocyte at 12 months after discharge
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10^3/µL
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Change from Baseline Leukocyte at 12 months after discharge
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Thrombocyte
時間枠：Change from Baseline Thrombocyte at 4 months after discharge
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10^3/µL
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Change from Baseline Thrombocyte at 4 months after discharge
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Thrombocyte
時間枠：Change from Baseline Thrombocyte at 12 months after discharge
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10^3/µL
|
Change from Baseline Thrombocyte at 12 months after discharge
|
|
Blood Glucose
時間枠：Change from Baseline Blood Glucose at 4 months after discharge
|
mg/dL
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Change from Baseline Blood Glucose at 4 months after discharge
|
|
Blood Glucose
時間枠：Change from Baseline Blood Glucose at 12 months after discharge
|
mg/dL
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Change from Baseline Blood Glucose at 12 months after discharge
|
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Sodium
時間枠：Change from Baseline Sodium at 4 months after discharge
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mEq/L
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Change from Baseline Sodium at 4 months after discharge
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Sodium
時間枠：Change from Baseline Sodium at 12 months after discharge
|
mEq/L
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Change from Baseline Sodium at 12 months after discharge
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Potassium
時間枠：Change from Baseline Sodium at 4 months after discharge
|
mEq/L
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Change from Baseline Sodium at 4 months after discharge
|
|
Potassium
時間枠：Change from Baseline Sodium at 12 months after discharge
|
mEq/L
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Change from Baseline Sodium at 12 months after discharge
|
|
Calcium
時間枠：Change from Baseline Sodium at 4 months after discharge
|
mEq/L
|
Change from Baseline Sodium at 4 months after discharge
|
|
Calcium
時間枠：Change from Baseline Sodium at 12 months after discharge
|
mEq/L
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Change from Baseline Sodium at 12 months after discharge
|
|
Serum Creatinine
時間枠：Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
|
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Serum Creatinine
時間枠：Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Total Bilirubin
時間枠：Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Total Bilirubin
時間枠：Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Indirect Bilirubin
時間枠：Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Indirect Bilirubin
時間枠：Change from Baseline Sodium at 12 months after discharge
|
mg/dL
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Change from Baseline Sodium at 12 months after discharge
|
|
High-density lipoprotein (HDL) cholesterol
時間枠：Change from Baseline Sodium at 4 months after discharge
|
mg/dL
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Change from Baseline Sodium at 4 months after discharge
|
|
High-density lipoprotein (HDL) cholesterol
時間枠：Change from Baseline Sodium at 12 months after discharge
|
mg/dL
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Change from Baseline Sodium at 12 months after discharge
|
|
Low-density lipoprotein (LDL) cholesterol
時間枠：Change from Baseline Sodium at 4 months after discharge
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mg/dL
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Change from Baseline Sodium at 4 months after discharge
|
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Low-density lipoprotein (LDL) cholesterol
時間枠：Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Aspartate Aminotransferase
時間枠：Change from Baseline Sodium at 4 months after discharge
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U/L
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Change from Baseline Sodium at 4 months after discharge
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Aspartate Aminotransferase
時間枠：Change from Baseline Sodium at 12 months after discharge
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U/L
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Change from Baseline Sodium at 12 months after discharge
|
|
Alanine aminotransferase
時間枠：Change from Baseline Sodium at 4 months after discharge
|
U/L
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Change from Baseline Sodium at 4 months after discharge
|
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Alanine aminotransferase
時間枠：Change from Baseline Sodium at 12 months after discharge
|
U/L
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Change from Baseline Sodium at 12 months after discharge
|
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Alkaline Phosphatase
時間枠：Change from Baseline Sodium at 4 months after discharge
|
U/L
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Change from Baseline Sodium at 4 months after discharge
|
|
Alkaline Phosphatase
時間枠：Change from Baseline Sodium at 12 months after discharge
|
U/L
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Change from Baseline Sodium at 12 months after discharge
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Triglyceride
時間枠：Change from Baseline Sodium at 4 months after discharge
|
mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Triglyceride
時間枠：Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
|
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Total Cholesterol
時間枠：Change from Baseline Sodium at 4 months after discharge
|
mg/dL
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Change from Baseline Sodium at 4 months after discharge
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Total Cholesterol
時間枠：Change from Baseline Sodium at 12 months after discharge
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mg/dL
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Change from Baseline Sodium at 12 months after discharge
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Albumin
時間枠：Change from Baseline Sodium at 4 months after discharge
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g/dL
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Change from Baseline Sodium at 4 months after discharge
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Albumin
時間枠：Change from Baseline Sodium at 12 months after discharge
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g/dL
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Change from Baseline Sodium at 12 months after discharge
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glucose in urine
時間枠：Change from Baseline Sodium at 4 months after discharge
|
mg/dL
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Change from Baseline Sodium at 4 months after discharge
|
|
glucose in urine
時間枠：Change from Baseline Sodium at 12 months after discharge
|
mg/dL
|
Change from Baseline Sodium at 12 months after discharge
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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。
スポンサー
捜査官
- 主任研究者：Fatma DEMIR KORKMAZ, Professor、Ege University Faculty of Nursing 35000, Izmir, Turkey
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。
一般刊行物
- Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C; American College of Sports Medicine; American Heart Association. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Circulation. 2007 Aug 28;116(9):1094-105. doi: 10.1161/CIRCULATIONAHA.107.185650. Epub 2007 Aug 1.
- Zelle DM, Kok T, Dontje ML, Danchell EI, Navis G, van Son WJ, Bakker SJ, Corpeleijn E. The role of diet and physical activity in post-transplant weight gain after renal transplantation. Clin Transplant. 2013 Jul-Aug;27(4):E484-90. doi: 10.1111/ctr.12149. Epub 2013 Jun 13.
- Zelle DM, Corpeleijn E, Klaassen G, Schutte E, Navis G, Bakker SJ. Fear of Movement and Low Self-Efficacy Are Important Barriers in Physical Activity after Renal Transplantation. PLoS One. 2016 Feb 4;11(2):e0147609. doi: 10.1371/journal.pone.0147609. eCollection 2016.
- Lorenz EC, Amer H, Dean PG, Stegall MD, Cosio FG, Cheville AL. Adherence to a pedometer-based physical activity intervention following kidney transplant and impact on metabolic parameters. Clin Transplant. 2015 Jun;29(6):560-8. doi: 10.1111/ctr.12553. Epub 2015 May 26.
- Gustaw T, Schoo E, Barbalinardo C, Rodrigues N, Zameni Y, Motta VN, Mathur S, Janaudis-Ferreira T. Physical activity in solid organ transplant recipients: Participation, predictors, barriers, and facilitators. Clin Transplant. 2017 Apr;31(4). doi: 10.1111/ctr.12929. Epub 2017 Mar 14.
- Aakhus S, Dahl K, Widerøe TE. Cardiovascular disease in stable renal transplant patients in Norway: morbidity and mortality during a 5-yr follow-up. Clin Transplant. 2004 Oct;18(5):596-604.
- Ojo AO. Cardiovascular complications after renal transplantation and their prevention. Transplantation. 2006 Sep 15;82(5):603-11. doi: 10.1097/01.tp.0000235527.81917.fe.
- Berben L, Engberg SJ, Rossmeissl A, Gordon EJ, Kugler C, Schmidt-Trucksäss A, Klem ML, Sereika SM, De Simone P, Dobbels F, De Geest SM; B-SERIOUS consortium. Correlates and Outcomes of Low Physical Activity Posttransplant: A Systematic Review and Meta-Analysis. Transplantation. 2019 Apr;103(4):679-688. doi: 10.1097/TP.0000000000002543.
- Dontje ML, de Greef MH, Krijnen WP, Corpeleijn E, Kok T, Bakker SJ, Stolk RP, van der Schans CP. Longitudinal measurement of physical activity following kidney transplantation. Clin Transplant. 2014 Apr;28(4):394-402. doi: 10.1111/ctr.12325. Epub 2014 Mar 17.
- Gordon EJ, Prohaska TR, Gallant MP, Sehgal AR, Strogatz D, Yucel R, Conti D, Siminoff LA. Longitudinal analysis of physical activity, fluid intake, and graft function among kidney transplant recipients. Transpl Int. 2009 Oct;22(10):990-8. doi: 10.1111/j.1432-2277.2009.00917.x. Epub 2009 Jul 10.
- Hawkins MS, Sevick MA, Richardson CR, Fried LF, Arena VC, Kriska AM. Association between physical activity and kidney function: National Health and Nutrition Examination Survey. Med Sci Sports Exerc. 2011 Aug;43(8):1457-64. doi: 10.1249/MSS.0b013e31820c0130.
- Svensson M, Jardine A, Fellström B, Holdaas H. Prevention of cardiovascular disease after renal transplantation. Curr Opin Organ Transplant. 2012 Aug;17(4):393-400. doi: 10.1097/MOT.0b013e3283560a3b. Review.
- Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009 Nov;9 Suppl 3:S1-155. doi: 10.1111/j.1600-6143.2009.02834.x.
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 (実際)
2020年11月19日
一次修了 (予想される)
2022年11月1日
研究の完了 (予想される)
2022年11月1日
試験登録日
最初に提出
2021年3月30日
QC基準を満たした最初の提出物
2021年8月6日
最初の投稿 (実際)
2021年8月12日
学習記録の更新
投稿された最後の更新 (実際)
2021年8月12日
QC基準を満たした最後の更新が送信されました
2021年8月6日
最終確認日
2021年8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。