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PMID- 28763548
OWN - NLM
STAT- In-Process
DA  - 20170801
LR  - 20170801
IS  - 1538-3598 (Electronic)
IS  - 0098-7484 (Linking)
VI  - 318
IP  - 5
DP  - 2017 Aug 01
TI  - Effect of Oral Methylprednisolone on Clinical Outcomes in Patients With IgA
      Nephropathy: The TESTING Randomized Clinical Trial.
PG  - 432-442
LID - 10.1001/jama.2017.9362 [doi]
AB  - Importance: Guidelines recommend corticosteroids in patients with IgA nephropathy
      and persistent proteinuria, but the effects remain uncertain. Objective: To
      evaluate the efficacy and safety of corticosteroids in patients with IgA
      nephropathy at risk of progression. Design, Setting, and Participants: The
      Therapeutic Evaluation of Steroids in IgA Nephropathy Global (TESTING) study was 
      a multicenter, double-blind, randomized clinical trial designed to recruit 750
      participants with IgA nephropathy (proteinuria greater than 1 g/d and estimated
      glomerular filtration rate [eGFR] of 20 to 120 mL/min/1.73 m2 after at least 3
      months of blood pressure control with renin-angiotensin system blockade] and to
      provide follow-up until 335 primary outcomes occurred. Interventions: Patients
      were randomized 1:1 to oral methylprednisolone (0.6-0.8 mg/kg/d; maximum, 48
      mg/d) (n = 136) or matching placebo (n = 126) for 2 months, with subsequent
      weaning over 4 to 6 months. Main Outcomes and Measures: The primary composite
      outcome was end-stage kidney disease, death due to kidney failure, or a 40%
      decrease in eGFR. Predefined safety outcomes were serious infection, new
      diabetes, gastrointestinal hemorrhage, fracture/osteonecrosis, and cardiovascular
      events. The mean required follow-up was estimated to be 5 years. Results: After
      randomization of 262 participants (mean age, 38.6 [SD, 11.1] years; 96 [37%]
      women; eGFR, 59.4 mL/min/1.73 m2; urine protein excretion, 2.40 g/d) and 2.1
      years' median follow-up, recruitment was discontinued because of excess serious
      adverse events. Serious events occurred in 20 participants (14.7%) in the
      methylprednisolone group vs 4 (3.2%) in the placebo group (P = .001; risk
      difference, 11.5% [95% CI, 4.8%-18.2%]), mostly due to excess serious infections 
      (11 [8.1%] vs 0; risk difference, 8.1% [95% CI, 3.5%-13.9%]; P < .001), including
      2 deaths. The primary renal outcome occurred in 8 participants (5.9%) in the
      methylprednisolone group vs 20 (15.9%) in the placebo group (hazard ratio, 0.37
      [95% CI, 0.17-0.85]; risk difference, 10.0% [95% CI, 2.5%-17.9%]; P = .02).
      Conclusions and Relevance: Among patients with IgA nephropathy and proteinuria of
      1 g/d or greater, oral methylprednisolone was associated with an increased risk
      of serious adverse events, primarily infections. Although the results were
      consistent with potential renal benefit, definitive conclusions about treatment
      benefit cannot be made, owing to early termination of the trial. Trial
      Registration: clinicaltrials.gov Identifier: NCT01560052.
FAU - Lv, Jicheng
AU  - Lv J
AD  - Renal Division, Department of Medicine, Peking University First Hospital,
      Beijing, China2The George Institute for Global Health, University of New South
      Wales, Sydney, Australia.
FAU - Zhang, Hong
AU  - Zhang H
AD  - Renal Division, Department of Medicine, Peking University First Hospital,
      Beijing, China.
FAU - Wong, Muh Geot
AU  - Wong MG
AD  - The George Institute for Global Health, University of New South Wales, Sydney,
      Australia.
FAU - Jardine, Meg J
AU  - Jardine MJ
AD  - The George Institute for Global Health, University of New South Wales, Sydney,
      Australia.
FAU - Hladunewich, Michelle
AU  - Hladunewich M
AD  - Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
FAU - Jha, Vivek
AU  - Jha V
AD  - The George Institute for Global Health, New Delhi, India5University of Oxford,
      Oxford, United Kingdom.
FAU - Monaghan, Helen
AU  - Monaghan H
AD  - The George Institute for Global Health, University of New South Wales, Sydney,
      Australia.
FAU - Zhao, Minghui
AU  - Zhao M
AD  - Renal Division, Department of Medicine, Peking University First Hospital,
      Beijing, China.
FAU - Barbour, Sean
AU  - Barbour S
AD  - The University of British Columbia, Vancouver, British Columbia, Canada.
FAU - Reich, Heather
AU  - Reich H
AD  - University Health Network, Toronto, Ontario, Canada.
FAU - Cattran, Daniel
AU  - Cattran D
AD  - University Health Network, Toronto, Ontario, Canada.
FAU - Glassock, Richard
AU  - Glassock R
AD  - David Geffen School of Medicine, University of California-Los Angeles.
FAU - Levin, Adeera
AU  - Levin A
AD  - The University of British Columbia, Vancouver, British Columbia, Canada.
FAU - Wheeler, David
AU  - Wheeler D
AD  - Royal Free and University College Medical School, London, United Kingdom.
FAU - Woodward, Mark
AU  - Woodward M
AD  - The George Institute for Global Health, University of New South Wales, Sydney,
      Australia10The George Institute for Global Health, University of Oxford, Oxford, 
      United Kingdom11Department of Epidemiology, Johns Hopkins University, Baltimore, 
      Maryland.
FAU - Billot, Laurent
AU  - Billot L
AD  - The George Institute for Global Health, University of New South Wales, Sydney,
      Australia.
FAU - Chan, Tak Mao
AU  - Chan TM
AD  - University of Hong Kong, Hong Kong, China.
FAU - Liu, Zhi-Hong
AU  - Liu ZH
AD  - Research Institute of Nephrology, Jinling Hospital, Nanjing, China.
FAU - Johnson, David W
AU  - Johnson DW
AD  - Australasian Kidney Trials Network, University of Queensland, Brisbane,
      Australia.
FAU - Cass, Alan
AU  - Cass A
AD  - The George Institute for Global Health, University of New South Wales, Sydney,
      Australia15Menzies School of Health Research, Charles Darwin University, Darwin, 
      Australia.
FAU - Feehally, John
AU  - Feehally J
AD  - University of Leicester, Leicester, United Kingdom.
FAU - Floege, Jurgen
AU  - Floege J
AD  - Division of Nephrology and Clinical Immunology, RWTH Aachen University, Aachen,
      Germany.
FAU - Remuzzi, Giuseppe
AU  - Remuzzi G
AD  - Mario Negri Institute for Pharmacological Research and Clinical Research Centre
      for Rare Diseases, Bergamo, Italy.
FAU - Wu, Yangfeng
AU  - Wu Y
AD  - Peking University Clinical Research Institute, Beijing, China.
FAU - Agarwal, Rajiv
AU  - Agarwal R
AD  - Indiana University School of Medicine, Indianapolis.
FAU - Wang, Hai-Yan
AU  - Wang HY
AD  - Renal Division, Department of Medicine, Peking University First Hospital,
      Beijing, China.
FAU - Perkovic, Vlado
AU  - Perkovic V
AD  - The George Institute for Global Health, University of New South Wales, Sydney,
      Australia.
CN  - TESTING Study Group
LA  - eng
PT  - Journal Article
PL  - United States
TA  - JAMA
JT  - JAMA
JID - 7501160
EDAT- 2017/08/02 06:00
MHDA- 2017/08/02 06:00
CRDT- 2017/08/02 06:00
AID - 2646717 [pii]
AID - 10.1001/jama.2017.9362 [doi]
PST - ppublish
SO  - JAMA. 2017 Aug 1;318(5):432-442. doi: 10.1001/jama.2017.9362.