scholarly journals Treatment effects of Chinese medicine (Yi-Qi-Qing-Jie herbal compound) combined with immunosuppression therapies in IgA nephropathy patients with high-risk of end-stage renal disease (TCM-WINE): study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Shen Li ◽  
Jin-pu Li
Keyword(s):  
High Risk ◽  
Renal Disease ◽  
Iga Nephropathy ◽  
End Stage Renal Disease ◽  
Controlled Trial ◽  
Eligible Patient ◽  
Study Phase ◽  
Double Blind ◽  
Stage Renal Disease ◽  
End Stage

Abstract Background IgA nephropathy (IgAN) is the most common glomerular disease worldwide. It has a high incidence in Asians and is more likely to progress to end-stage renal disease (ESRD). For high-risk IgAN, which is clinically characterized by massive proteinuria and renal dysfunction, however, there has been no international consensus on treatment options. Compared with other developed countries, IgAN patients in China are often found to have severe kidney function loss at initial diagnosis. Yi-Qi-Qing-Jie formula (YQF; a compound recipe of Chinese medicinal herbs) has shown potential renal protection in our previous clinical studies. To further confirm the efficacy and safety of YQF in the treatment of high-risk IgAN, we have designed a prospective double-blind randomized placebo-controlled trial. Methods/design The TCM-WINE study is a single-center, prospective, double-blind randomized placebo-controlled trial. We plan to randomize 60 participants with biopsy-proven IgAN to a YQF combined group (YQF compound combined with prednisolone, and cyclophosphamide if necessary) or an immunosuppression group (placebo-YQF combined with prednisolone, and cyclophosphamide if necessary). The two groups will enter a 48-week in-trial treatment phase and receive post-trial follow-up until study completion (3 years). All patients will receive optimal supportive care. The primary composite outcome is defined as the first occurrence of a 40% decrease in estimated glomerular filtration rate (eGFR) from the baseline lasting for 3 months, initiating continuous renal replacement treatment, or death due to chronic kidney disease (CKD) during the 3-year study phase. The secondary endpoint events are defined as the mean annual eGFR decline rate (eGFR slope, ml/min per 1.73 m2 per year), which is calculated by the eGFR regression curve for each eligible patient, and proteinuria remission (prescribed as proteinuria < 0.5 g/day) at weeks 24, 36, and 48 during the in-trial phase. The remission rate of symptoms and inflammation status will be evaluated at week 48. Safety monitoring and assessment will be undertaken during the study. Discussion The TCM-WINE study will evaluate the effects and safety of YQF combined therapy compared with immunosuppression monotherapy on the basis of the optimal supportive treatment in high-risk IgAN. The evidence from this study will provide a novel, effective, and safe Chinese characteristic therapy for high-risk IgAN patients. Trial registration ClinicalTrials.gov, NCT03418779. Registered on 18 June 2018.

scholarly journals Treatment effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) combined With immunosuppression therapies in patients of IgA Nephropathy with high-risk of ESRD (TCM-WINE): study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Shen Li ◽  
Jin-pu Li
Keyword(s):  
Randomized Controlled Trial ◽  
High Risk ◽  
Iga Nephropathy ◽  
Controlled Trial ◽  
Combined Therapy ◽  
Eligible Patient ◽  
Developed Countries ◽  
Study Phase ◽  
Double Blind ◽  
Randomized Controlled

Abstract Background: IgA nephropathy (IgAN) is the most common glomerular disease worldwide. It has a high incidence in Asians and is more likely to progress to end-stage renal disease (ESRD). However, for high-risk IgAN clinically characterized by massive proteinuria and renal dysfunction, there has been no international consensus on treatment options. Compared with other developed countries, Chinese IgAN patients are often found to have severe kidney function loss at the initial diagnosis. Yi-Qi-Qing-Jie Formula Granule (a compound recipe of Chinese medicinal herbs, YQF) has shown potential renal protection in our previous clinical studies. To further confirm the efficacy and safety of YQF in the treatment of high-risk IgAN, we design a prospective double-blind randomized placebo-controlled trial. Methods/Design: The TCM-WINE study is a single-center, prospective, double-blind placebo-randomized controlled trial. We plan to randomize 60 participants with biopsy-proven IgAN to YQF combined group (YQF compound, combined with prednisolone, and cyclophosphamide if necessary) and immunosuppression group (placebo-YQF, combined with prednisolone, and cyclophosphamide if necessary). The two groups will enter 48-week in-trial treatment phase and receive post-trial follow-up till study completion (3-year). All patients will receive optimal supportive care. The primary composite outcome is defined as the first occurrence of a 40% decrease in estimated glomerular filtration rate (eGFR) from the baseline lasting for 3 months, initiating continuous renal replacement treatment or death due to chronic kidney disease (CKD), during the 3-year study phase. Secondary endpoint events are defined as the mean annual eGFR decline rate (eGFR-Slope, ml/min per 1.73 m 2 per year) which is calculated by the eGFR regression curve for each eligible patient, and proteinuria remission (prescribed as proteinuria<0.5g/day) at week 24, 36, 48 during the in-trial phase. Safety monitoring and assessment will be undertaken during the study . Discussion: TCM-WINE study will evaluate effects and safety of YQF combined therapy compared with immunosuppression monotherapy on basis of optimal supportive treatment in high-risk IgAN. The evidence from this study will provide a novel, effective and safe Chinese characteristics therapy for high-risk IgAN patients. Trial registration: Clinicaltrials.gov, identifier: NCT03418779. Registered on 18 June 2018. https://clinicaltrials.gov/show/NCT03418779

scholarly journals Treatment effects of Chinese medicine (Yi-Qi-Qing-Jie herbal compound) combined with immunosuppression therapies in patients of IgA nephropathy with high-risk of ESRD (TCM-WINE): study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Jin-pu Li ◽  
Shen Li
Keyword(s):  
High Risk ◽  
Iga Nephropathy ◽  
Remission Rate ◽  
Controlled Trial ◽  
Combined Therapy ◽  
Eligible Patient ◽  
Developed Countries ◽  
Study Phase ◽  
International Consensus ◽  
Double Blind

Abstract Background: IgA nephropathy (IgAN) is the most common glomerular disease worldwide. It has a high incidence in Asians and is more likely to progress to end-stage renal disease (ESRD). For high-risk IgAN, which is clinically characterized by massive proteinuria and renal dysfunction, however, there has been no international consensus on treatment options. Compared with other developed countries, IgAN patients in China are often found to have severe kidney function loss at initial diagnosis. Yi-Qi-Qing-Jie Formula Granule (a compound recipe of Chinese medicinal herbs, YQF) has shown potential renal protection in our previous clinical studies. To further confirm the efficacy and safety of YQF in the treatment of high-risk IgAN, we design a prospective double-blind randomized placebo-controlled trial. Methods/Design: The TCM-WINE study is a single-center, prospective, double-blind randomized placebo-controlled trial. We plan to randomize 60 participants with biopsy-proven IgAN to YQF combined group (YQF compound, combined with prednisolone, and cyclophosphamide if necessary) and immunosuppression group (placebo-YQF, combined with prednisolone, and cyclophosphamide if necessary). The two groups will enter 48-week in-trial treatment phase and receive post-trial follow-up till study completion (3-year). All patients will receive optimal supportive care. The primary composite outcome is defined as the first occurrence of 40% decrease in estimated glomerular filtration rate (eGFR) from the baseline lasting for 3 months, initiating continuous renal replacement treatment or death due to chronic kidney disease (CKD), during the 3-year study phase. The secondary endpoint events are defined as the mean annual eGFR decline rate (eGFR-Slope, ml/min per 1.73 m2 per year) which is calculated by the eGFR regression curve for each eligible patient, and proteinuria remission (prescribed as proteinuria<0.5g/day) at week 24, 36, 48 during the in-trial phase. The remission rate of symptoms and inflammation status will be evaluated respectively at week 48. Safety monitoring and assessment will be undertaken during the study. Discussion: TCM-WINE study will evaluate effects and safety of YQF combined therapy compared with immunosuppression monotherapy on basis of optimal supportive treatment in high-risk IgAN. The evidence from this study will provide a novel, effective and safe Chinese characteristic therapy for high-risk IgAN patients. Trial registration: Clinicaltrials.gov, identifier: NCT03418779. Registered on 18 June 2018. https://clinicaltrials.gov/show/NCT03418779

scholarly journals Low Birth Weight and Risk of Progression to End Stage Renal Disease in IgA Nephropathy—A Retrospective Registry-Based Cohort Study

PLoS ONE ◽  
2016 ◽  
Vol 11 (4) ◽  
pp. e0153819 ◽  
Author(s):  
Paschal Ruggajo ◽  
Einar Svarstad ◽  
Sabine Leh ◽  
Hans-Peter Marti ◽  
Anna Varberg Reisæther ◽  
...  
Keyword(s):  
Cohort Study ◽  
Birth Weight ◽  
Low Birth Weight ◽  
Renal Disease ◽  
Iga Nephropathy ◽  
End Stage Renal Disease ◽  
Risk Of Progression ◽  
Stage Renal Disease ◽  
End Stage

scholarly journals Anticoagulation in Patients with End-Stage Renal Disease and Atrial Fibrillation: Confusion, Concerns and Consequences

2020 ◽  
Vol 22 (3) ◽  
pp. 306-316
Author(s):  
Narender Goel ◽  
Deepika Jain ◽  
Danny B. Haddad ◽  
Divya Shanbhogue
Keyword(s):  
Atrial Fibrillation ◽  
Renal Disease ◽  
End Stage Renal Disease ◽  
Clinical Decision Making ◽  
Controlled Trial ◽  
Oral Anticoagulants ◽  
Increased Risk ◽  
Stage Renal Disease ◽  
End Stage ◽  
Esrd Patients

End-stage renal disease (ESRD) patients have a higher prevalence of diabetes mellitus, hypertension, congestive heart failure and advanced age, along with an increased incidence of non-valvular atrial fibrillation (AF), thereby increasing the risk for cerebrovascular accidents. Systemic anticoagulation is therefore recommended in patients with ESRD with AF to reduce the risk and complications from thromboembolism. Paradoxically, these patients are at an increased risk of bleeding due to great degree of platelet dysfunction and impaired interaction between platelet and endothelium. Currently, CHA2DS2-VASc and Hypertension, Abnormal liver/kidney function, Stroke, Bleeding, Labile INR, Elderly, Drugs or alcohol (HAS-BLED) are the recommended models for stroke risk stratification and bleeding risk assessment in patients with AF. There is conflicting data regarding benefits and risks of medications such as antiplatelet agents, warfarin and direct oral anticoagulants in ESRD patients with AF. Moreover, there is no randomized controlled trial data to guide the clinical decision making. Hence, a multi-disciplinary approach with annual re-evaluation of treatment goals and risk-benefit assessment has been recommended. In this article, we review the current recommendations with risks and benefits of anticoagulation in patients with ESRD with AF.

Sign in / Sign up

Export Citation Format

Share Document