scholarly journals Safety and tolerability of prescribed usage of Derise® (Darbepoetin Alfa, Hetero) in symptomatic anemia: A Phase IV Post-Authorization Study

2020 ◽  
Author(s):  
Shubhadeep Sinha ◽  
Vamsi Krishna Bandi ◽  
Bala Reddy Bheemareddy ◽  
Pankaj Thakur ◽  
Sreenivasa Chary ◽  
...  
Keyword(s):  
Renal Failure ◽  
Chronic Renal Failure ◽  
Adverse Events ◽  
Darbepoetin Alfa ◽  
Treatment Phase ◽  
Enzyme Linked Immunosorbent Assay ◽  
P Value ◽  
End Of Treatment ◽  
Phase Iv

Abstract Background This phase IV, post–authorisation safety & efficacy study evaluated the safety, immunogenicity and tolerability of prescribed usage of Darbepoetin alfa, (DA-α, manufactured by Hetero Biopharma) for the treatment of symptomatic anemia in Indian patients with chronic renal failure.Methods Adults patients of either gender suffering from anemia associated with chronic renal failure patients were prescribed and treated with DA-α and followed up for 1 year. 503 patients were enrolled into the study, of which 121 patients were evaluated for immunogenicity at the end of treatment phase (up to 24 weeks) and after 1-year (52 weeks after start of treatment) follow up. Safety end points were the incidence of treatment emergent adverse events (TEAEs) and immunogenicity as assessed by anti-drug antibody titers using validated enzyme linked immunosorbent assay (ELISA) methods. Efficacy end point included improvement in the hemoglobin, mean change in Hemoglobin (Hb) levels from baseline to end of treatment (up to 24 weeks). Statistical analyses were performed to explore and analyze details of individual case safety reports of adverse events such as incidence, severity, seriousness, outcome, duration, action taken, and causality relationship of individual adverse event (AE) to the prescribed study drug. Results 87 AEs were reported in this study and most of them were mild to moderate in intensity. No deaths or serious adverse events (SAEs) were reported in this study. Anti-drug antibodies were not detected in any subject at the end of treatment phase and after 12 months long term follow up period. Baseline mean Hemoglobin value was 8.34 (SD 1.24) g/dL and last visit mean Hemoglobin value was 10.42 (SD 1.28) g/dL. The mean difference between baseline and last visit was 2.10 [2.00, 2.20], statistically significant (p-value <.0001). Clinical Trial Registry Number: CTRI/2017/04/008338 [Registered on CTRI http://ctri.nic.in/Clinicaltrials/login.php : 12/04/2017]; Trial Registered Retrospectively

Safety and tolerability of prescribed usage of Derise® (Darbepoetin Alfa, Hetero) in symptomatic anemia: A Post Marketing Surveillance Study

2020 ◽  
Author(s):  
Shubhadeep Sinha ◽  
Vamsi Krishna Bandi ◽  
Bala Reddy Bheemareddy ◽  
Pankaj Thakur ◽  
Sreenivasa Chary ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Adverse Events ◽  
Darbepoetin Alfa ◽  
P Value ◽  
End Of Treatment ◽  
Post Marketing Surveillance ◽  
Post Marketing

Abstract Background This post marketing surveillance, observational, prospective, safety study evaluated the safety, tolerability and long term immunogenicity of prescribed usage of Darbepoetin alfa, (DA-α, manufactured by Hetero Biopharma) in Indian patients with chronic kidney disease with anemia.Methods All patients with anemia of chronic kidney disease prescribed Hetero-Darbepoetin were the target patient population. The present study gathered the data from 503 Hetero-Darbepoetin alfa prescribed patients. This study collected information of patient demography, patient's medical history, concomitant medications, action taken with respect to Hetero-Darbepoetin-alfa, AE details (AE term, start date, stop date, severity, action taken, outcome and causality), periodic Hemoglobin (Hb) levels and abnormal laboratory tests results until treatment is discontinued or the patient is lost to follow-up. Immunogenicity data was collected in 121 patients at the end of treatment and after 1 year. Statistical analyses were performed to explore and analyze details of individual case safety reports of adverse events such as incidence, severity, seriousness, outcome, duration, action taken, and causality relationship of individual adverse event (AE) to the prescribed study drug. Results 87 AEs were reported in this study and most of them were mild to moderate in intensity. No deaths or serious adverse events (SAEs) were reported in this study. Anti-drug antibodies were not detected in any subject at the end of treatment phase and after 12 months long term follow up period. Baseline mean Hemoglobin value was 8.34 (SD 1.24) g/dL and last visit mean Hemoglobin value was 10.42 (SD 1.28) g/dL. The mean difference between baseline and last visit was 2.10 [2.00, 2.20], statistically significant (p-value <.0001). Conclusions The safety and tolerability of the usage of DA-α (manufactured by Hetero Biopharma) is similar to that reported in the published literature of the innovator. No patients showed anti-drug antibodies after treatment. Additionally, the patients also showed significant improvement in hemoglobin levels, compared to baseline.Clinical Trial Registry Number: CTRI/2017/04/008338 [Registered on CTRI http://ctri.nic.in/Clinicaltrials/login.php : 12/04/2017]; Trial Registered Retrospectively

scholarly journals Prostate-Specific Antigen: From Promising to Disappointment Tool for Diagnosis of Chronic Renal Failure in Predialysis Patients

2021 ◽  
Vol 07 (02) ◽  
pp. 082-084
Author(s):  
Ali Abdul Hussein S Al-Janabi
Keyword(s):  
Prostate Cancer ◽  
Renal Failure ◽  
Chronic Renal Failure ◽  
Prostate Specific Antigen ◽  
Specific Antigen ◽  
Enzyme Linked Immunosorbent Assay ◽  
Elderly Men ◽  
A Value ◽  
Total Psa ◽  
Moderate Elevation

Abstract Introduction Prostate-specific antigen (PSA) is a biomarker commonly used for detection of prostate cancer. Its viability as a marker for diagnosis of chronic renal failure (CRF) in predialysis patients was investigated. Methods Sera from 230 patients with CRF were analyzed by enzyme-linked immunosorbent assay (ELISA) for determining total PSA (tPSA) levels before hemodialysis. Results Of the patients investigated, 98.69% had a normal PSA level with a value less than 4 ng/mL. Three elderly men with both kidney failure showed a moderate elevation of PSA level. Conclusion PSA is considered a nonsignificant indicator for diagnosis of CRF.

scholarly journals Predictors of adverse prognosis in patients with infective endocarditis in a surgical referral center

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Scheggi ◽  
I Olivotto ◽  
N Ceschia ◽  
I Merilli ◽  
V Andrei ◽  
...  
Keyword(s):  
Renal Failure ◽  
Infective Endocarditis ◽  
Adverse Events ◽  
Ejection Fraction ◽  
Relapse Rate ◽  
Left Ventricular Ejection ◽  
All Cause Mortality ◽  
Fatal Adverse Events

Abstract Background Despite optimal medical and surgical treatment, mortality in infective endocarditis (IE) remains high. Aim of this study was to identify predictors of long term mortality for any cause, adverse event rate, relapse rate and valvular dysfunction at follow-up, in a high-volume surgical center. Methods We retrospectively analyzed 358 consecutive patients (127 women) admitted to our department with definite diagnosis of IE not device-related. IE occurred on native valves in 224 patients (63%); the infection involved the aortic valve in 192 (54%), mitral valve in 139 (39%) and tricuspid valve in 26 (7%). Overall 285 (80%) patients underwent surgery and 73 (20%) were treated conservatively, 38 due to absence of surgical indication and 35 due to refusal or prohibitive surgical risk. Long-term follow-up was obtained by structured telephone interviews. Primary endpoints were all-cause mortality, freedom from recurrent endocarditis, postoperative incidence of major adverse events (hospitalization for any cause, pace-maker implantation, new onset of atrial fibrillation, sternal dehiscence), worsening of left ventricular ejection fraction (LVEF) and valvular dysfunction. Results Mean age was 65 years (SD 15.2). Mean vegetation length was 8.9 mm (SD 7.6). Endocarditis was left-sided in 332 (93%). Average follow-up was 6 months. At univariable analysis, mortality was associated with female gender (p=0.031), age (p&lt;0.001), higher EuroSCORE 2 (p&lt;0.001), chronic renal failure (p&lt;0.001), diabetes (p=0.002), brain embolism on presentation (p=0.05), double valve infection (p=0.008), low ejection fraction (p&lt;0.001), paravalvular extension (p=0.031), prosthetic infection (p=0.018), exclusion from surgery if indicated (p&lt;0.001), high procalcitonin levels (p=0.035); factors associated with a significantly lower mortality were streptococcal infection (p=0.04; OR 0.34) and early surgery (p=0.009, OR 0.55). At multivariable analysis independent predictors of all-cause mortality were lower EF, EuroSCORE2, procalcitonin levels and diabetes. Non-fatal adverse events were associated with renal failure (p 0.035, OR 2.8). Relapse rate was associated with S aureus infection (p=0.005, OR 3.8), right-sided endocarditis (p&lt;0.001, OR 6.7) and drug abuse (p&lt;0.001, OR 9.4). Conclusions The present study shows that low EF, EuroSCORE2, procalcitonin levels and diabetes are independent predictors of death in patients with IE. Non-fatal adverse events are more frequent in patients with renal failure. Relapse rate is higher in drug abusers. These informations may help personalize follow-up strategies after acute admission for IE. Funding Acknowledgement Type of funding source: None

scholarly journals Hubungan Frekuensi Hemodialisis dengan Tingkat Stres pada Pasien Gagal Ginjal Kronik yang Menjalani Hemodialisis

2018 ◽  
Vol 1 (2) ◽  
pp. 139-153
Author(s):  
Fitri Rahayu ◽  
Topan Fernandoz ◽  
Rafika Ramlis
Keyword(s):  
Renal Failure ◽  
Chronic Renal Failure ◽  
Study Design ◽  
Significant Relationship ◽  
P Value ◽  
Analytic Method ◽  
Stress Levels ◽  
Almost All ◽  
Moderate Stress

The aim of this study was to determine whether there is a relationship between hemodialysis frequency stress levels in patients with chronic renal failure undergoing hemodialysis  at hemodialysis installation  of dr. M. Yunus hospital Bengkulu City 2016. The study design used was a descriptive analytic method to explain each variable studied. The results showed that there was a significant relationship between the frequency of hemodialysis with the level of stress in patients with chronic renal failure, almost all respondents often undergo hemodialysis in hemodialysis installation in dr. M.Yunus hospital in Bengkulu city, of a total of 67 respondents almost half of respondents suffered moderate stress levels and no significant association between HD frequency with the stress levels of patients with CKD in Haemodialysis installation with p value 0.041 smaller than 0.05. The results of this study are expected to add insight and knowledge about the disease of CKD, and and is expected to continue this research in the context of a deeper and broader variables. Keywords: Frequency, Hemodialysis, Stress Levels.  

scholarly journals Residual renal function and blood count in patients on continuous ambulatory peritoneal dialysis

2006 ◽  
Vol 134 (11-12) ◽  
pp. 503-508
Author(s):  
Natasa Jovanovic ◽  
Mirjana Lausevic ◽  
Biljana Stojimirovic
Keyword(s):  
Renal Failure ◽  
Renal Function ◽  
Peritoneal Dialysis ◽  
Chronic Renal Failure ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Blood Count ◽  
Residual Renal Function ◽  
Co Morbidity ◽  
Positive Correlations

Introduction:Most of patients with chronic renal failure are affected by normochromic, normocytic anemia caused by different etiological factors. Anemia causes a series of symptoms in chronic renal failure, which can hardly be recognized from the uremic signs. Anemia adds to morbidity and mortality rates in patients affected by advanced chronic renal failure. Blood count partially improves during the first months after starting the chronic renal replacement therapy, in correlation with the quality of depuration program, with extension of erythrocyte lifetime and with hemoconcentration due to reduction of plasma volume. Recent trials found that higher residual renal function (RRF) significantly reduced co-morbidity, the rate and duration of hospitalization and risk of treatment failure. Objective: The aim of the study was to follow blood count parameters in 32 patients on chronic continuous ambulatory peritoneal dialysis (CAPD) during the first six months of treatment, to evaluate the influence of demographic and clinical factors on blood count and RRF, and to examine the correlation between RRF and blood count parameters. Method: A total of 32 patients affected by end-stage renal disease of different major cause during the first six months of CADP treatment were studied. RRF and blood count were evaluated as well as their relationship during the follow-up. Results: Blood count significantly improved in our patients during the first six months of CAPD treatment even if Hb and HTC failed to reach normal values. Iron serum level slightly decreased because of more abundant erythropoiesis and iron utilization during the first six months of treatment. RRF slightly decreased. After six months of CAPD treatment, the patients with higher RRF had significantly higher Hb, HTC and erythrocyte number and a lot of positive correlations between RRF and anemia markers were observed. Conclusion: After 6-month follow-up period, the patients with higher RRF had significantly higher blood count parameters, and several positive correlations between RRF and blood count markers were confirmed.

scholarly journals Coping Mechanisms and Stress Adaptation in Chronic Kidney Failure Patients Underwent Hemodialysis Therapy in RSUD Waled Kabupaten Cirebon

2020 ◽  
Vol 7 (2) ◽  
pp. 27-31
Author(s):  
Bambang Adi Purnomo ◽  
Yani Kamasturyani ◽  
Cecep Wahyudin
Keyword(s):  
Renal Failure ◽  
Chronic Renal Failure ◽  
Kidney Failure ◽  
Chronic Kidney Failure ◽  
Coping Mechanisms ◽  
Rank Test ◽  
Stress Adaptation ◽  
P Value ◽  
Cross Sectional ◽  
Spearman Rank

Chronic renal failure is a disease that results in a progressive and gradual decline in renal function that requires hemodialysis therapy. In Indonesia, there were 198,575 patients chronic kidney failure in 2018. The number of undergoing hemodialysis therapy is 132,142 patients. The hemodialysis routine causes tension, anxiety, stress and depression in patient. The purpose of this study was to determine the relationship between coping mechanisms and stress adaptation in chronic renal failure patients undergoing hemodialysis therapy ant Waled Hospital. The method of this research was descriptive correlational with a cross sectional approach. This research used purposive sampling technique amounted to 79 respondents. The instrument of this research was a questionnaire Jaloweic Coping Scale (JCS) and stress adaptation questionnaire. Data analysis used the spearman rank test. Place of research at Waled Hospital, Cirebon Regency during July 2020.  The result showed that most respondents had an adaptive category as many as 55 adaptation showed the results of most respondents had an adaptive category as many as 55 respondents with a percentage (69.6%). The spearman rank test showed p value <α and r<1, which means that there was a moderate an positive relationship between coping mechanisms and stress adaptation (p value=0,000 < α=0.05 and r=0.593). The is a relationship between coping mechanisms and stress adaptation in chronic renal failure patients undergoing hemodialysis therapy. The better coping mechanism is carries out, the adaptive stress that arises will be adaptive so that the patient can adjust and be able to cope with the stress he is experiencing.

scholarly journals Intradermal hepatitis B vaccination in patients with advanced chronic renal failure: immunogenicity and follow-up

2007 ◽  
Vol 25 (7) ◽  
pp. 849-855 ◽  
Author(s):  
E. O. MORAIS ◽  
M. R. RESENDE ◽  
A. M. OLIVEIRA ◽  
V. M. SINKOC ◽  
M. T. GARCIA ◽  
...  
Keyword(s):  
Renal Failure ◽  
Chronic Renal Failure ◽  
Hepatitis B ◽  
Hepatitis B Vaccination

Ten Years’ Experience with Chronic Peritoneal Dialysis at a Community Hospital

1980 ◽  
Vol 1 (7) ◽  
pp. 124-129 ◽  
Author(s):  
S. Paul Handa ◽  
Sheila Greer
Keyword(s):  
Renal Failure ◽  
Peritoneal Dialysis ◽  
Chronic Renal Failure ◽  
Kidney Transplant ◽  
Community Hospital ◽  
Patient Survival ◽  
Chronic Peritoneal Dialysis ◽  
Better Than

This paper describes the experience of a community hospital in the treatment of chronic renal failure with intermittent (IPD) and continuous ambulatory peritoneal dialysis (CAPD) in 61 adult patients over a 10 year period. In the earlier years of this decade, 14 patients, dialysed through temporary catheters, were transferred to hemodialysis or received a kidney transplant. Later, a long-term IPD and CAPD treatment through permanent peritoneal catheters was instituted in 25 and 22 patients respectively. Over a similar but not simultaneous follow-up period, the patient survival with CAPD was better than with IPD.

Kaposi's Sarcoma in Young Patients Treated with Orthovoltage Irradiation and Having a Minimum Follow-Up of Forty-Six Years

2009 ◽  
Vol 95 (3) ◽  
pp. 325-328 ◽  
Author(s):  
Stefano Pergolizzi ◽  
Anna Santacaterina ◽  
Michele Gaeta ◽  
Alfredo Blandino
Keyword(s):  
Renal Failure ◽  
Radiation Therapy ◽  
Chronic Renal Failure ◽  
Clinical Outcome ◽  
Kaposi's Sarcoma ◽  
Young Patients ◽  
Kaposi’S Sarcoma ◽  
Orthovoltage Radiotherapy

Purpose To describe the clinical outcome and to evaluate the role of orthovoltage radiotherapy in the treatment of young (less than 30 years old) Mediterranean men with Kaposi's sarcoma. Patients and methods We reviewed the records of 198 consecutive patients with Kaposi's sarcoma treated with orthovoltage radiation therapy at our department between January 1920 and December 1987. Result We found three young shepherds, aged less than 30 years, with an available follow-up ranging from 45 to 67 years. One patient died at the age of 84 years of chronic renal failure while suffering from cutaneous Kaposi's sarcoma; two patients are still alive with recurrent Kaposi's sarcoma. Conclusions We presume that an indolent form of Kaposi's sarcoma may occur in young men. This very indolent form can be controlled for the duration of the patient's life by judiciously applied radiation therapy.

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