John A. Manley, MD

Training/Education

  • 1998-2000 / Emory University School of Medicine, Fellowship, Nephrology
  • 1995-1998 / Emory University School of Medicine, Residency, Internal Medicine
  • 1991-1995 / Oklahoma University School of Medicine, Doctor of Medicine
  • 1987-1991 / Oklahoma University, Bachelor of Science    

Work Experience

  • 2000-Present / Clinical Nephrologist, Mountain Kidney and Hypertension Associates, PA
  • 1998-2000 / Fellow in Nephrology, Emory University School of Medicine
  • 1995-1998 / Medical Residency, Internal Medicine, Emory University School of Medicine

Credentials

  • Medical License / North Carolina Physician License - 88018
  • Certification / North Carolina Medical Board - 200000534
  • American Board of Internal Medicine, 1998, 2009
  • American Board of Nephrology, 2000, 2010, 2021
  • Certified in Renal Ultrasound at completion of nephrology fellowship

Hospital Affiliations

  • Mission-St. Joseph's Health System
  • Harris Regional Hospital
  • CarePartners Rehabilitation Hospital
  • Haywood Regional Medical Center
  • McDowell Hospital
  • Transylvania Regional Hospital
  • Highlands-Cashiers Regional Hospital
  • Angel Medical Center
  • Blue Ridge Regional Hospital

Professional Affiliations

  • American Society of Nephrology
  • American College of Physicians
  • Buncombe County Medical Society
  • Renal Physicians Association

Committees

  • Member of Mission Hospital Pharmacy Formulary Committee

Honors and Awards

  • Phi Beta Kappa Honor Society, 1991
  • Arts and Sciences Honor Roll, 1987-1991

Research

  • A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of an Oral Calcimimetic Agent (Cinacalcet) in Secondary Hyperparathyroidism of End Stage Renal Disease
  • A Phase 3 Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (Cinacalcet) in Secondary Hyperparathyroidism of End Stage Renal Disease Treated with Hemodialysis
  • A Randomized, Open-Label, Parallel Design Study of Sevelamer Phosphate Binder Versus Calcium-Based Phosphorus Binders in Hemodialysis Patients
  • A Placebo-Controlled, Double-Blind, Extension Study to Assess the Long-Term Safety of an Oral Calcimimetic Agent (Cinacalcet) in Secondary Hyperparathyroidism of End Stage Renal Disease
  • A Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of an Oral Calcimimetic Agent (Cinacalcet) When Two Different Vitamin D Regimens are Used in Subjects with Secondary Hyperparathyroidism of End Stage Renal Disease
  • TARGET: Treatment Strategies to Achieve Recommended K/DOQI Goals in ESRD Patients on Cinacalcet
  • Sub-Investigator
    • A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate the Efficacy of StaphVax Vaccine in Adults on Hemodialysis
  • Sub-Investigator
    • A Phase 3, Randomized, Active-Controlled, Open-Label Study of the Safety and Efficacy of AF37702 Injection for the Correction of Anemia in Patients with Chronic Renal Failure not on Dialysis and not on Erythropoiesis Stimulating Agent (ESA) Treatment
  • A Randomized, Multi-Center, Two Group Clinical Trial to Assess the Best Treatment for Patients with High Blood Pressure and Renal Artery Stenosis: Stenting with Anti-Hypertensive Medical Therapy Compared to Medical Therapy Alone
  • Principal Investigator
    • Dialysis Outcomes and Practice Patterns (DOPPS 4) – A Prospective, Longitudinal Observational Study of Nationally Representative Samples of Hemodialysis Facilities and Subjects Across 12 Countries
  • Sub-Investigator
    • A Phase III, Randomized, Double-Blind, Placebo Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients with Moderate to Severe Chronic Kidney Disease
  • Sub-Investigator
    • A Randomized Evaluation of the Efficacy and Safety of Ferric Carboxymaltose in Patients with Iron Deficiency Anemia and Impaired Renal Function
  • Principal Investigator
    • An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 compared with Sevelamer  Followed by a Randomised Comparison of PA21-Maintenance Dose Versus PA21-Low Dose in Dialysis Patients with Hyperphosphatemia
  • Principal Investigator
    • An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Phase 3 Study to Investigate the Long term Safety, Tolerability and Efficacy of PA21 Compared with Sevelamer Carbonate in Dialysis Patients with Hyperphosphataemia, Extension Study
  • Principal Investigator
    • A Randomized, Placebo-Controlled, Phase III Study of Dialysate Containing Soluble Ferric Pyrophosphate (SFP) in Chronic Kidney Disease Patients Receiving Hemodialysis: The Continuous Replacement Using Iron Soluble Equivalents (CRUISE 1) Study
  • Principal Investigator
    • A Three Period, 58-Week Safety and Efficacy Trial of KRX-0502 in Patients with End Stage Renal Disease (ESRD) on Dialysis
  • Principal Investigator
    • A Long-Term Safety Extension Trial of KRX-0502 (ferric citrate) in Patients with End-Stage Renal Disease (ESRD) on Dialysis
  • Principal Investigator
    • A Phase 2 Study of KRX0502 (Ferric Citrate) in Managing Serum Phosphorus and Iron Deficiency in Anemic Subjects with Stage III to V Chronic Kidney Disease Not on Dialysis
  • Principal Investigator
    • Dialysis Outcomes and Practice Patterns Study, 2012?2015 (DOPPS 5)
  • Sub-Investigator
    • A Randomized, Double-Blinded, Placebo-Controlled, Crossover, Multicenter Phase III Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in Chronic Kidney Disease Patients Receiving Chronic Hemodialysis
  • Sub-Investigator
    • Open Label Uncontrolled Extension Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in Chronic Kidney Disease Patients Receiving Chronic Hemodialysis
  • Principal Investigator
    • Adjuvant Peritoneal Dialysis on a Background of Thrice-Weekly Hemodialysis
  • Principal Investigator
    • Chronic Kidney Disease Outcomes and Practice Patterns Study (CKDopps)
  • Principal Investigator
    • A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Pyridorin™ (pyridoxamine dihydrochloride) in Subjects With Nephropathy Due to Type 2 Diabetes
  • Sub-Investigator
    • A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of the Safety and Efficacy of Roxadustat in the Treatment of Anemia in Dialysis Patients
  • Principal Investigator
    • A Phase 3 Study of KRX-0502 (Ferric Citrate) for the Treatment of Iron Deficiency Anemia in Adult Subjects with Non-Dialysis Dependent Chronic Kidney Disease
  • Sub-Investigator
    • A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
  • Principal Investigator
    • A Randomized, Multicountry, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects with Type 2 Diabetes and Nephropathy - SONAR: Study of Diabetic Nephropathy with Atrasentan
  • Sub-Investigator
    • A Phase 3, Randomized, Placebo Controlled, Prospective, Multicenter Study with Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects with Chronic Kidney Disease
  • Principal Investigator
    • A Phase 3, Randomized, Open-label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease
  • Principal Investigator
    • A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients with Chronic Kidney Disease (DAPA-CKD)
  • Principal Investigator
    • A Phase 4 Study of KRX-0502 (Ferric Citrate) Dose Regimens in Subjects With Non-Dialysis Dependent CKD and Iron Deficiency Anemia: The COMPASS Trial  
  • Principal Investigator
    • A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy in End-Stage Renal Disease (ESRD) Subjects with Hyperphosphatemia
  • Sub-Investigator
    • A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of KBP-5074 in Patients with Moderate-to-Severe Chronic Kidney Disease and Uncontrolled Hypertension (BLOCK/CKD)
  • Sub-Investigator
    • A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Selonsertib in Subjects with Moderate to Advanced Diabetic Kidney Disease
  • Sub-Investigator
    • A multicenter international randomized parallel group double-blind placebo-controlled clinical trial of EMPAgliflozin once daily to assess cardio-renal outcomes in patients with chronic KIDNEY disease (EMPA-CKD)
  • Principal Investigator
    • A Two-Part Proof-of-Concept Phase 2 Study: An Open-Label Dose-Ranging Phase (Part A) Followed by a Randomized, Single-Blind, Placebo-Controlled Phase (Part B) Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia (ReduKx)
  • Sub-Investigator
    • A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (AFFINITY)
  • Sub-Investigator
    • A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (ALIGN)
  • Sub-Investigator
    • A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (ORIGIN)
  • Sub-Investigator
    • A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SNF472 When Added to Background Care for the Treatment of Calciphylaxis
  • Sub-Investigator
    • Phase 3b Multicenter, Open-Label Single Arm Study of Roxadustat: Either as Conversion from an Erythropoiesis Stimulating Agent (ESA), or as Initial Anemia Treatment in Hemodialysis (HD) Patients 

Abstracts and Published Articles

  • Manley, JA. How Echogenic is Echogenic? Quantitative Acoustics of the Renal Cortex.  American Journal of Kidney Diseases; Vol 37: 706-711.
  • Abstract presented in 2000 American Society of Nephrology on quantification of renal echogenicity
  • Abstract presented in 2000 American Society of Nephrology on renal sonographic changes in ATN and prerenal azotemia
  • Abstract presented in 2000 National Kidney Foundation on renal sonographic changes in ATN and prerenal azotemia
  • Abstract presented at the 2013 American Society of Nephrology on Ferric Citrate, an Oral Phosphate Binder That Also Reduces IV Iron and Erythropoietin
  • Ferric Citrate Controls Phosphorus and Delivers Iron in Dialysis Patients.  J Am Soc Nephrol. 2015 26 (2): 493-503
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