365ACUTE TUBULO-INTERSTTIAL NEPHRITIS IN A PATIENT WITH HEPATITIS B ON TENOFOVIR. Hima Bindu Yalamanchili, Bridgeport Hospital, Bridgeport, Connec�cut, USA, Sandeep Ravi, Gilbert W. Moeckel, George Abdelsayed, Irwin Feintzeig. We are repor�ng a pa�ent who presented with acute renal failure secondary to acute tubulo-inters��al nephri�s in temporal associa�onwith tenofovir. 67 year-old African American male with past medical history of chronic ac�ve Hepa��s B infec�on treated with tenofovir and hypertension presented to our hospital with a one week history of nausea, poor appe�te, poor oral intake and generalized weakness. His medica�ons were atorvasta�n, hydrochlorothiazide, and atenolol. There were neither any new medica�ons nor any dosage changes prior to current presenta�on. Laboratory data disclosed BUN 173mg/dL, serum crea�nine 18.6mg/dL (a baseline crea�nine 1.23), sodium 126mmol/L, potassium 3.5mmol/L, chloride 82mmol/L, bicarbonate 22mmol/L, calcium 6.6mg/dL, phosphorus 12.5 mg/dL, crea�nine phosphokinase of 741 IU/l and the anion gap was 23. Renal ultrasound, complement levels, ANA, ANCA and HIV were normal or nega�ve. Urine analysis was nega�ve for casts with rare urine eosinophils. Renal biopsy demonstrated acute tubulo-inters��al nephri�s with focal glomerulosclerosis. His renal func�on gradually improved with transient hemo-dialysis (10 days), Tenofovir discon�nua�on and 3-day course of pulsed methylprednisolone followed by prednisone taper. To our knowledge acute tubulo-inters��al nephri�s due to tenofovirwas not previously described in literature. Few previous case reports of AIN were reported in pa�ents with HIV on combina�on of tenofovirand atazanavir. Tenofovir alone was associated with Fanconi's syndrome and proximal tubular dysfunc�on. With this case report we want to emphasize that acute tubule inters��al nephri�s should be considered in the differen�al diagnosisof renal failure associated with tenofovir and early discon�nua�on oftenofovir is essen�al for recovery of renal func�on.

366HIGH BLOOD PRESSURE IS A RISK OF CKD IN JAPANESE POPULATION WITH AND WITHOUT HISTORY OF HYPERTENSION---RESUTLTS FROM KEEPJAPANMitsuru 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 historyof 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, theincidence 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.

367PEGINESATIDE 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

1Affymax, Inc., Palo Alto, CA, 2Takeda Pharmaceuticals, Deerfield, IL,3Chronic 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) Gender (% male) 56%1 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% Congestive Heart Failure 34.7%1,2 46.0% Cerebrovascular Disease 13.6%1,2 19.3% Peripheral Vascular Disease 31.1%1,2 27.1% Hemoglobin (g/dL) 11.9 (11.0-12.9) 11.4 (10.9-11.7)Ferritin <100 ng/mL +TSAT < 20%

3.4% 1.0%

Epoetin alfa dose (U/kg/week) 171 (83-334)2 131 (70-228)3

Data presented as weighted 1 % or median (25th - 75th percentile); 2Medicare 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.

NKF 2011 Spring Clinical Meetings Abstracts

Am J Kidney Dis. 2011;57(4):A1-A108A108