A Non-Interventional, Modified Delphi Study to Establish Consensus Recommendations on the Optimal Management of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients in South Korea

The purpose of this study is to establish an expert consensus recommendations on managing patients with mHSPC in South Korea, and to provide clinicians with a comprehensive guide to support their clinical decision making. There are no secondary objectives for this study.

开始日期2024-07-10

申办/合作机构

Astellas Pharma Korea, Inc.

NCT06011954 / RecruitingN/A

Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea

Enfortumab vedotin (or PADCEV Injection) is a treatment for cancer in the bladder lining (urothelial cancer). PADCEV Injection is now available to treat this cancer.
People in this study will be adults in South Korea with locally advanced or metastatic urothelial cancer. Metastatic means the cancer has spread to other parts of the body. During their care, the person's doctor will have prescribed PADCEV Injection and other medicines to treat their cancer. People in the study will be treated according to their clinic's standard practice. This study is about collecting information only.
This study will survey people who know they are receiving PADCEV Injection. The aims of the study are to check outcomes of treatment with PADCEV and record any medical problems during the study.
Once a doctor has prescribed PADCEV Injection, a person in the study will be observed for up to 48 weeks (about 1 year) after their first dose. During this time, a person's medical records will be reviewed to check for any medical problems and to follow the condition of their cancer. If a person in the study stops taking PADCEV Injection sooner than 48 weeks, records will be reviewed until 30 days (1 month) after each person's last dose of PADCEV Injection or until they start a different medicine for their cancer.

开始日期2023-11-01

申办/合作机构

Astellas Pharma Korea, Inc.

[+1]

NCT04691648 / RecruitingN/A

An Observational Study to Assess the Safety of Xospata® 40 mg Tablet When Administered in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-Like Tyrosine Kinase 3 (FLT3) Mutation

The objective of this study is to describe the observed safety profile of Xospata® 40 mg tablet when administered in patients with relapsed or refractory AML with FLT3 mutation in routine clinical practice in Korea.

开始日期2022-06-17

申办/合作机构

Astellas Pharma Korea, Inc.

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2021-01-01·Journal of the American Society of Nephrology1区 · 医学

Comparison of the Efficacy and Safety of Tacrolimus and Low-Dose Corticosteroid with High-Dose Corticosteroid for Minimal Change Nephrotic Syndrome in Adults

1区 · 医学

Article

作者: Koo, Ho Seok ; Jin, Dong-Chan ; Oh, Jieun ; Ihm, ChunGyoo ; Jiang, Hongsi ; Park, Jung Hwan ; Kim, Yong Chul ; An, Won Suk ; Kim, Yoon-Goo ; Lee, Jung Eun ; Kim, Sung Gyun ; Kim, Yong-Soo ; Chin, Ho Jun ; Kim, Yong-Lim ; Chae, Dong-Wan ; Lee, Kang Wook ; Lee, Sang Koo ; Lee, Hyuncheol

Significance StatementSteroid resistance, relapse, and side effects are common issues in use of high-dose steroids as first-line treatment for adult minimal change nephrotic syndrome. Tacrolimus is used as a steroid-sparing immunosuppressant to reduce adverse effects of long-term or repeated steroid treatment, but no large-scale randomized study has compared combined tacrolimus and low-dose steroid with high-dose steroid in treating minimal change nephrotic syndrome in adults. In this open-label randomized trial, the authors found that treatment with tacrolimus plus low-dose steroid was noninferior to high-dose steroid for complete remission at 8 weeks, and that treatment with a maintenance dose of tacrolimus during steroid tapering reduced the relapse rate, with no clinically-relevant safety differences. This indicates that tacrolimus is an effective alternative to high-dose steroids in this disease, although investigation into long-term safety is warranted.BackgroundTacrolimus is used as a steroid-sparing immunosuppressant in adults with minimal change nephrotic syndrome. However, combined treatment with tacrolimus and low-dose steroid has not been compared with high-dose steroid for induction of clinical remission in a large-scale randomized study.MethodsIn this 24-week open-label noninferiority study, we randomized 144 adults with minimal change nephrotic syndrome to receive 0.05 mg/kg twice-daily tacrolimus plus once-daily 0.5 mg/kg prednisolone, or once-daily 1 mg/kg prednisolone alone, for up to 8 weeks or until achieving complete remission. Two weeks after complete remission, we tapered the steroid to a maintenance dose of 5–7.5 mg/d in both groups until 24 weeks after study drug initiation. The primary end point was complete remission within 8 weeks (urine protein: creatinine ratio <0.2 g/g). Secondary end points included time until remission and relapse rates (proteinuria and urine protein: creatinine ratio >3.0 g/g) after complete remission to within 24 weeks of study drug initiation.ResultsComplete remission within 8 weeks occurred in 53 of 67 patients (79.1%) receiving tacrolimus and low-dose steroid and 53 of 69 patients (76.8%) receiving high-dose steroid; this difference demonstrated noninferiority, with an upper confidence limit below the predefined threshold (20%) in both intent-to-treat (11.6%) and per-protocol (17.0%) analyses. Groups did not significantly differ in time until remission. Significantly fewer patients relapsed on maintenance tacrolimus (3–8 ng/ml) plus tapered steroid versus tapered steroid alone (5.7% versus 22.6%, respectively; P=0.01). There were no clinically relevant safety differences.ConclusionsCombined tacrolimus and low-dose steroid was noninferior to high-dose steroid for complete remission induction in adults with minimal change nephrotic syndrome. Relapse rates were significantly lower with maintenance tacrolimus and steroid compared with steroid alone. No clinically-relevant differences in safety findings were observed.

2019-12-31·Korean Journal of Transplantation

Development and validation of the Kidney Transplantation and Quality of Life, a Korean questionnaire to assess the general quality of life and other health issues associated with medication change in kidney transplant recipients

Article

作者: Choi, Ju Young ; Kim, Sehyun ; Kim, Sung Joo ; Rhu, Jinsoo ; Lee, Kyo Won ; Chung, Young Jae ; Jung, Jin Sang ; Park, Jae Berm

BackgroundThis study aimed to develop and validate the Kidney Transplantation and Quality of Life (KTQoL) questionnaire to evaluate the quality of life (QoL) in Korean kidney transplantation (KT) patients. During the validation, the KTQoL was used to compare the QoL of KT patients before and after conversion from twice-daily to a once-daily regimen of tacrolimus.MethodsConstruct and content validity of the 24-item KTQoL was evaluated using factor analysis and a panel of experts, respectively. The questionnaire was validated in 50 KT patients, conducted before and after conversion from twice-daily to once-daily tacrolimus. Internal consistency was evaluated based on Cronbach's alpha coefficient.ResultsThe KTQoL showed high internal consistency (Cronbach's alpha 0.71 to 0.88). Besides the Concerns category, both the general and specific QoL of KT patients were relatively good (≥70% of positive responses) and did not change markedly after conversion to the once-daily regimen (42.9±8.8 vs. 43.6±8.6, P=0.740). After conversion, men scored better than women in total KTQoL, Specific QoL, and Symptoms, while employed patients had better Daily Life scores and showed greater improvement in Daily Life scores compared with unemployed patients.ConclusionsThe KTQoL seems to be a reliable instrument to evaluate general and specific QoL in Korean KT patients. Most patients evaluated their QoL positively. Conversion to once-daily tacrolimus had no significant effect on QoL in the total sample of KT patients. The QoL of men and/or employed persons might improve more after conversion to once-daily tacrolimus.

2019-01-01·Journal of Rheumatic Diseases

Effectiveness and Safety of Tacrolimus in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-modifying Anti-rheumatic Drugs: The TREASURE Study

作者: Jiang, Hongsi ; Lee, Hye Soon ; Chung, Won Tae ; Hong, Seung Jae ; Sheen, Dong Hyuk ; Yoo, Dae Hyun ; Lee, Sang Heon ; Lee, Sungmin

Objective. Evaluate effectiveness/safety of tacrolimus in patients in Korea with active rheumatoid arthritis (RA) and unsuccessful response to disease-modifying anti-rheumatic drugs (DMARDs). Methods. Open-label, single-arm, non-comparative, 24-week, Phase-IV study in patients with active RA who had taken DMARDs for ＞6 months. Following a washout period, tacrolimus was initiated (baseline-12 weeks; dose 2 mg/day and 1.5 mg/day in patients aged ≤65 and ＞65 years, respectively). After 12 weeks, dose could be adjusted (remaining between 1~3 mg); treatment continued to 24 weeks. Primary endpoint was American College of Rheumatology 20% improvement (ACR20) (baseline-Week 24). Secondary endpoints included ACR50/ACR70 response, disease-activity score in 28 joints (DAS28) erythrocyte sedimentation rate (ESR), number of tender/ swollen joints, and bone mineral density (BMD) loss. Adverse events (AEs) were recorded. Results. Overall, 121 patients were analysed. Mean ±standard deviation tacrolimus dose baseline-Week 24 was 1.81±0.47 mg/day. After 24 weeks, 64.5%, 39.7%, and 19.0% of patients were ACR20, ACR50, and ACR70 responders, respectively. DAS28-ESR score decreased from 5.5±0.8 (baseline) to 3.7±1.5 (Week 24; p＜0.0001); number of tender/swollen joints decreased. Between screening and Week 24, change in BMD-T score in lumbar and femur regions was -0.06±0.38 (p=0.1550) and -0.04±0.28 (p=0.0936), respectively, with no significant change in International Society for Clinical Densitometry classification. Fifty-six (46.3%) patients experienced 93 AEs; 75.3% were mild. No unexpected safety signals identified. Conclusion. Tacrolimus therapy was associated with a high proportion of ACR responders, and improved DAS28-ESR score and physical joint function during the study. Tacrolimus may be a suitable therapy for DMARD-resistant patients with RA. (J Rheum Dis 2019;26:20-30)

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