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365 Acute Tubulo-Intersttial Nephritis in a Patient With Hepatitis B on Tenofovir
NKF 2011 Spring Clinical Meetings Abstracts
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367
ACUTE TUBULO-INTERSTTIAL NEPHRITIS IN A PATIENT WITH HEPATITIS B ON TENOFOVIR. Hima Bindu Yalamanchili, Bridgeport Hospital, Bridgeport, Conneccut, USA, Sandeep Ravi, Gilbert W. Moeckel, George Abdelsayed, Irwin Feintzeig. We are reporng a paent who presented with acute renal failure secondary to acute tubulo-intersal nephris in temporal associaon with tenofovir. 67 year-old African American male with past medical history of chronic acve Hepas B infecon treated with tenofovir and hypertension presented to our hospital with a one week history of nausea, poor appete, poor oral intake and generalized weakness. His medicaons were atorvastan, hydrochlorothiazide, and atenolol. There were neither any new medicaons nor any dosage changes prior to current presentaon. Laboratory data disclosed BUN 173mg/dL, serum creanine 18.6mg/dL (a baseline creanine 1.23), sodium 126mmol/L, potassium 3.5mmol/L, chloride 82mmol/L, bicarbonate 22mmol/L, calcium 6.6mg/dL, phosphorus 12.5 mg/dL, creanine phosphokinase of 741 IU/l and the anion gap was 23. Renal ultrasound, complement levels, ANA, ANCA and HIV were normal or negave. Urine analysis was negave for casts with rare urine eosinophils. Renal biopsy demonstrated acute tubulo-intersal nephris with focal glomerulosclerosis. His renal funcon gradually improved with transient hemo-dialysis (10 days), Tenofovir disconnuaon and 3-day course of pulsed methylprednisolone followed by prednisone taper. To our knowledge acute tubulo-intersal nephris due to tenofovir was not previously described in literature. Few previous case reports of AIN were reported in paents with HIV on combinaon of tenofovir and atazanavir. Tenofovir alone was associated with Fanconi's syndrome and proximal tubular dysfuncon. With this case report we want to emphasize that acute tubule intersal nephris should be considered in the differenal diagnosis of renal failure associated with tenofovir and early disconnuaon of tenofovir is essenal for recovery of renal funcon.
PEGINESATIDE PHASE 3 TRIAL SUBJECTS VS A RANDOM SAMPLE OF UNITED STATES HEMODIALYSIS PATIENTS Alex Yang1, Ali Hariri2, Thomas Arneson3, Allan Collins3, Chris Hanzlik3, James Ebben3, Bhavik J. Pandya2, Hong Tang1, Krishna Polu1, Vandana Mathur1 1 Affymax, Inc., Palo Alto, CA, 2Takeda Pharmaceuticals, Deerfield, IL, 3 Chronic Disease Research Group, Minneapolis, MN. Peginesatide, a PEGylated, investigational, peptide-based ESA in development for anemia of chronic renal failure, was studied in hemodialysis patients (vs. epoetin alfa) in EMERALD 1, a US-only Phase 3 randomized active-controlled trial. To determine if the trial population was similar to the general US hemodialysis population we compared their baseline characteristics to a random stratified sample of the US adult prevalent in-center hemodialysis population (Medicare Clinical Performance Measures (CPM), 10-12/2006). Characteristic Medicare CPM EMERALD 1 N 8,743 793 Age (years) 62 (51-73) 58 (49-67) 1 Gender (% male) 56% 55.1% Race (%White/Afr- Amer) 55%/38%1 48%/47% Weight (kg) 74.5 (62.7-89.0) 1 80.3 (69.0-95.5) Diabetes 57.2%1,2 56.6% Myocardial Infarction 8.4%1,2 14.9% 1,2 Congestive Heart Failure 34.7% 46.0% 1,2 Cerebrovascular Disease 13.6% 19.3% 1,2 Peripheral Vascular Disease 31.1% 27.1% Hemoglobin (g/dL) 11.9 (11.0-12.9) 11.4 (10.9-11.7) Ferritin <100 ng/mL 3.4% 1.0% +TSAT < 20% 2 Epoetin alfa dose (U/kg/week) 171 (83-334) 131 (70-228)3 Data presented as weighted 1 % or median (25th - 75th percentile); 2 Medicare 2006 claims data; 3Last weekly dose prior to randomization EMERALD 1 enrolled a large number of patients from epidemiologically-relevant demographic groups and with diabetes, higher body weights, and cardiovascular conditions typical for the US hemodialysis population.
366 HIGH BLOOD PRESSURE IS A RISK OF CKD IN JAPANESE POPULATION WITH AND WITHOUT HISTORY OF HYPERTENSION---RESUTLTS FROM KEEP JAPAN Mitsuru Yanai, Kazuyoshi Okada, Susumu Takahashi International Kidney Evaluation Association Japan, Tokyo, Japan. The International Kidney Evaluation Association Japan (IKEAJ) started the Japanese version of Kidney Early Evaluation Program (KEEP JAPAN) following the US National Kidney Foundation since 2006. The 1537 participants with diabetes or hypertension, or family history of diabetes, hypertension, or kidney disease (KEEP group) and 587 participants without above risk factors (non-KEEP group) were included. Overall, mean age was 54.4 ± 17.8 years; 969 were men and 1155 were women. Of them, 451 participants were yearly examined up to forth year. Of KEEP group, CKD prevalence was 28.4%, defined by positive albumin-creatinine ratio (= or >30 mg/gCr) and decreased estimated glomerular filtration rate using Japanese equation (<60 ml/min). In contrast, of non-KEEP group, the prevalence was 15.5%. In KEEP group, 780 participants (50.8%) reported a history of hypertension, and of them, 429 participants (55.0%) had high blood pressure (= or >140/90 mmHg) and 122 (15.6%) had very high blood pressure (= or >160/100 mmHg). In the participants with history of hypertension, although the high blood pressure was not a significant risk of CKD (prevalence: 43.6%, odds ratio: 1.12 [95%CI: 0.84 to 1.50]), the very high blood pressure was a significant risk of CKD (prevalence: 52.4%, odds ratio: 1.63 [95%CI: 1.10 to 2.40]). Among 757 KEEP participants without history of hypertension, 148 participants (19.6%) had high blood pressure and their prevalence of CKD was 21.6% (odds ratio: 1.99 [95%CI: 1.26 to 3.16]). Similarly, among non-KEEP group who did not have history of hypertension, 135 participants (23.0%) had high blood pressure and their prevalence of CKD was 27.4% (odds ratio: 2.78 [95%CI: 1.73 to 4.47]). During the yearly follow-up, the incidence of CKD in KEEP group participants with high blood pressure was 57% (odds ratio: 2.65 [95%CI: 1.45 to 4.85]). In conclusion, as the measurement of blood pressure is essential for the examination in the evaluation program of CKD. The blood pressure control and the early identification of undiagnosed hypertension may prevent or delay the progression of CKD.
A108
Am J Kidney Dis. 2011;57(4):A1-A108
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367
ACUTE TUBULO-INTERSTTIAL NEPHRITIS IN A PATIENT WITH HEPATITIS B ON TENOFOVIR. Hima Bindu Yalamanchili, Bridgeport Hospital, Bridgeport, Conneccut, USA, Sandeep Ravi, Gilbert W. Moeckel, George Abdelsayed, Irwin Feintzeig. We are reporng a paent who presented with acute renal failure secondary to acute tubulo-intersal nephris in temporal associaon with tenofovir. 67 year-old African American male with past medical history of chronic acve Hepas B infecon treated with tenofovir and hypertension presented to our hospital with a one week history of nausea, poor appete, poor oral intake and generalized weakness. His medicaons were atorvastan, hydrochlorothiazide, and atenolol. There were neither any new medicaons nor any dosage changes prior to current presentaon. Laboratory data disclosed BUN 173mg/dL, serum creanine 18.6mg/dL (a baseline creanine 1.23), sodium 126mmol/L, potassium 3.5mmol/L, chloride 82mmol/L, bicarbonate 22mmol/L, calcium 6.6mg/dL, phosphorus 12.5 mg/dL, creanine phosphokinase of 741 IU/l and the anion gap was 23. Renal ultrasound, complement levels, ANA, ANCA and HIV were normal or negave. Urine analysis was negave for casts with rare urine eosinophils. Renal biopsy demonstrated acute tubulo-intersal nephris with focal glomerulosclerosis. His renal funcon gradually improved with transient hemo-dialysis (10 days), Tenofovir disconnuaon and 3-day course of pulsed methylprednisolone followed by prednisone taper. To our knowledge acute tubulo-intersal nephris due to tenofovir was not previously described in literature. Few previous case reports of AIN were reported in paents with HIV on combinaon of tenofovir and atazanavir. Tenofovir alone was associated with Fanconi's syndrome and proximal tubular dysfuncon. With this case report we want to emphasize that acute tubule intersal nephris should be considered in the differenal diagnosis of renal failure associated with tenofovir and early disconnuaon of tenofovir is essenal for recovery of renal funcon.
PEGINESATIDE PHASE 3 TRIAL SUBJECTS VS A RANDOM SAMPLE OF UNITED STATES HEMODIALYSIS PATIENTS Alex Yang1, Ali Hariri2, Thomas Arneson3, Allan Collins3, Chris Hanzlik3, James Ebben3, Bhavik J. Pandya2, Hong Tang1, Krishna Polu1, Vandana Mathur1 1 Affymax, Inc., Palo Alto, CA, 2Takeda Pharmaceuticals, Deerfield, IL, 3 Chronic Disease Research Group, Minneapolis, MN. Peginesatide, a PEGylated, investigational, peptide-based ESA in development for anemia of chronic renal failure, was studied in hemodialysis patients (vs. epoetin alfa) in EMERALD 1, a US-only Phase 3 randomized active-controlled trial. To determine if the trial population was similar to the general US hemodialysis population we compared their baseline characteristics to a random stratified sample of the US adult prevalent in-center hemodialysis population (Medicare Clinical Performance Measures (CPM), 10-12/2006). Characteristic Medicare CPM EMERALD 1 N 8,743 793 Age (years) 62 (51-73) 58 (49-67) 1 Gender (% male) 56% 55.1% Race (%White/Afr- Amer) 55%/38%1 48%/47% Weight (kg) 74.5 (62.7-89.0) 1 80.3 (69.0-95.5) Diabetes 57.2%1,2 56.6% Myocardial Infarction 8.4%1,2 14.9% 1,2 Congestive Heart Failure 34.7% 46.0% 1,2 Cerebrovascular Disease 13.6% 19.3% 1,2 Peripheral Vascular Disease 31.1% 27.1% Hemoglobin (g/dL) 11.9 (11.0-12.9) 11.4 (10.9-11.7) Ferritin <100 ng/mL 3.4% 1.0% +TSAT < 20% 2 Epoetin alfa dose (U/kg/week) 171 (83-334) 131 (70-228)3 Data presented as weighted 1 % or median (25th - 75th percentile); 2 Medicare 2006 claims data; 3Last weekly dose prior to randomization EMERALD 1 enrolled a large number of patients from epidemiologically-relevant demographic groups and with diabetes, higher body weights, and cardiovascular conditions typical for the US hemodialysis population.
366 HIGH BLOOD PRESSURE IS A RISK OF CKD IN JAPANESE POPULATION WITH AND WITHOUT HISTORY OF HYPERTENSION---RESUTLTS FROM KEEP JAPAN Mitsuru Yanai, Kazuyoshi Okada, Susumu Takahashi International Kidney Evaluation Association Japan, Tokyo, Japan. The International Kidney Evaluation Association Japan (IKEAJ) started the Japanese version of Kidney Early Evaluation Program (KEEP JAPAN) following the US National Kidney Foundation since 2006. The 1537 participants with diabetes or hypertension, or family history of diabetes, hypertension, or kidney disease (KEEP group) and 587 participants without above risk factors (non-KEEP group) were included. Overall, mean age was 54.4 ± 17.8 years; 969 were men and 1155 were women. Of them, 451 participants were yearly examined up to forth year. Of KEEP group, CKD prevalence was 28.4%, defined by positive albumin-creatinine ratio (= or >30 mg/gCr) and decreased estimated glomerular filtration rate using Japanese equation (<60 ml/min). In contrast, of non-KEEP group, the prevalence was 15.5%. In KEEP group, 780 participants (50.8%) reported a history of hypertension, and of them, 429 participants (55.0%) had high blood pressure (= or >140/90 mmHg) and 122 (15.6%) had very high blood pressure (= or >160/100 mmHg). In the participants with history of hypertension, although the high blood pressure was not a significant risk of CKD (prevalence: 43.6%, odds ratio: 1.12 [95%CI: 0.84 to 1.50]), the very high blood pressure was a significant risk of CKD (prevalence: 52.4%, odds ratio: 1.63 [95%CI: 1.10 to 2.40]). Among 757 KEEP participants without history of hypertension, 148 participants (19.6%) had high blood pressure and their prevalence of CKD was 21.6% (odds ratio: 1.99 [95%CI: 1.26 to 3.16]). Similarly, among non-KEEP group who did not have history of hypertension, 135 participants (23.0%) had high blood pressure and their prevalence of CKD was 27.4% (odds ratio: 2.78 [95%CI: 1.73 to 4.47]). During the yearly follow-up, the incidence of CKD in KEEP group participants with high blood pressure was 57% (odds ratio: 2.65 [95%CI: 1.45 to 4.85]). In conclusion, as the measurement of blood pressure is essential for the examination in the evaluation program of CKD. The blood pressure control and the early identification of undiagnosed hypertension may prevent or delay the progression of CKD.
A108
Am J Kidney Dis. 2011;57(4):A1-A108