The Division of Nephrology at Emory University Department of Pediatrics is devoted to providing expert diagnosis, treatment and follow-up care of infants, children and adolescents with renal conditions.

Chronic Kidney Disease in Children Prospective Cohort Study (CKiD III)

This is an observational study of children with chronic kidney disease. The primary goals of this study are to determine the risk factors for decline in kidney function and to define how a progressive decline in kidney function impacts neurocognitive function and behavior; the risk factors for cardiovascular disease; and growth failure and its associated morbidity.

Study information: https://clinicaltrials.gov/ct/show/NCT00327860?order=1

Recruitment status: Enrolling

Site Principal Investigator: Larry Greenbaum, MD, PhD

Study Coordinator: Segun Adeagbo (404) 727-0851

 

Children's Nephrotic Syndrome Study Network (cNEPTUNE)

The purpose of this study is to find markers of Nephrotic Syndrome (kidney disease with too much protein in the urine) in those who are newly diagnosed nephrotic syndrome. By collecting health information and laboratory samples, our goal is to learn more about these kidney diseases and find better ways to prevent and treat people with these kidney diseases.

Study information: http://clinicaltrials.gov/ct2/show/NCT01240564?  

Recruitment status: Enrolling

Site Principal Investigator: Larry Greenbaum, MD, PhD

Study Coordinator: Brian Lee (404) 712-9998

 

Cure Glomerulonephropathy Network (CureGN)

There are several different types of glomerular diseases, such as minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), membranous nephropathy (MN), and immunoglobulin A nephropathy (IgAN). Over time, these diseases may cause kidney damage. These kidney diseases are rare and because of that, it is difficult for individual researchers to gather a large enough number of people to effectively study underlying causes, identify markers of disease, and identify and evaluate new therapies. The purpose of CureGN is to gather a group of patients with glomerular disease to create a source of information and blood and urine samples, so that researchers can easily and effectively study glomerular disease.

Recruitment status: Enrolling

Site Principal Investigator: Larry Greenbaum, MD, PhD

Study Coordinator: Helina Iyob-Tessema (404) 727-7371

 

ACTH for Frequently Relapsing and Steroid Dependent Nephrotic Syndrome (ATLANTIS Study)

Currently, the standard treatment for frequently relapsing and steroid dependent nephrotic syndrome involves a variety of medications that suppress the immune system, which can produce serious side effects. We propose a study to examine the effects of a different medication, ACTH, on nephrotic syndrome. ACTH is a hormone naturally found in the body. Recently, in adult studies, ACTH has been shown to be effective for the treatment of nephrotic syndrome. It has also been shown to have mild and reversible side effects. ACTH is potentially an attractive therapeutic alternative for the treatment of frequently relapsing and steroid dependent nephrotic syndrome in children. Our study will randomly assign patients with frequently relapsing or steroid dependent nephrotic syndrome to either ACTH treatment or no treatment. This will allow us to study the effects of ACTH on this disease and its side effects, by comparing how patients do on ACTH treatment versus no treatment. We hypothesize that ACTH gel is superior to no treatment in maintaining remission in children with frequently relapsing or steroid dependent nephrotic syndrome.

Study information: https://clinicaltrials.gov/ct2/show/NCT02132195

Recruitment status: Enrolling

Site Principal Investigator: Larry Greenbaum, MD, PhD

Study Coordinator: Margo Kamel, PhD (404) 712-9923

 

A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Arms with Switchover, Pilot Study to Evaluate the Efficacy and Safety of Intravenous Abatacept in Treatment Resistant Nephrotic Syndrome (Focal Segmental Glomerulosclerosis/ Minimal Change)

The purpose of this study is evaluate if Abatacept is effective and safe in decreasing the level of protein loss in the urine in patients with excessive loss of protein in the urine (nephrotic syndrome) due to either focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). Candidates must have a prior kidney biopsy with either diagnosis. Another kidney biopsy will not be required as part of the study. Candidates must have failed or be intolerant of prior therapy for their kidney disease. The failed or intolerant therapy must include corticosteroids and at least one other drug. Candidates can be adults and children over the age of 6. Abatacept will be administered by venous infusion every 4 weeks.

Study information: https://clinicaltrials.gov/ct2/show/study/NCT02592798

Recruitment status: Enrolling

Site Principal Investigator: Larry Greenbaum, MD, PhD

Site coordinator: Brian Lee (404) 712-9998

 

An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients with Hyperphosphataemia

This a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients with Hyperphosphataemia. The aim of this Phase 3 clinical study is to demonstrate similar efficacy of PA21 (Velphoro) in paediatric and adolescent patients with CKD, and to provide safety and dosing information for this patient population. The Phoslyra (comparator) group provides information for a descriptive comparison of PA21 against a commonly used calcium-based phosphate binder (calcium acetate).

Study information: https://clinicaltrials.gov/ct2/show/NCT02688764

Recruitment status: Enrolling

Site Principal Investigator: Larry Greenbaum, MD, PhD

Site coordinator: Helina Iyob-Tessema (404) 727-7371

 

Evaluation of Potential Predictors of Disease Progression in Patients with aHUS, Including Genetics, Biomarkers, and Treatment (EVIDENCE)

This is a prospective, open-label study with no patient randomization. Treatment for atypical hemolytic uremic syndrome (aHUS) will remain observational and at the discretion of the treating physician. The purpose of this study is to assess disease manifestations of complement mediated thrombotic microangiopathy (TMA) and potential clinical predictors of disease manifestations and progression in patients with aHUS with or without eculizumab treatment in the clinical setting.

Study information: https://clinicaltrials.gov/ct2/show/NCT02614898

Recruitment status: Enrolling

Site Principal Investigator: Larry Greenbaum, MD, PhD

Site coordinator: Segun Adeagbo (404) 727-0851

 

A Phase 2/3 Trial of the the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome (CARDINAL)

This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome. The Phase 2 portion of the trial will be open-label and enroll up to 30 patients. The Phase 3 portion of the trial will be double-blind, randomized, placebo-controlled and will enroll up to 180 patients.

Study information: https://clinicaltrials.gov/ct2/show/NCT03019185

Recruitment status: Enrolling

Site Principal Investigator: Larry Greenbaum, MD, PhD

Site coordinator: Brian Lee (404) 712-9998

 

Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial (U-REAACT)

Study information: https://clinicaltrials.gov/ct2/show/NCT03045276

Recruitment status: Enrolling

Site Principal Investigator: Roshan George, MD

Study coordinator: Helina Iyob-Tessema (404-727-7371)

 

Urinary Biomarkers To Produce Improved Outcomes After Renal Transplantation (UTOPIA)

Recruitment status: Enrolling

Site Principal Investigator: Roshan George, MD

Study coordinator: Brian Lee (404-712-9998)

 

Transplant Recipient’s Adherence, Quality of Life and Outcomes In the context of Health Literacy (TRANQUIL Study)

The purpose of this study is to assess the association between health literacy, heath related quality of life, and long-term clinical outcome in kidney transplant recipients or patients preparing for a kidney transplant.

Recruitment status: Enrolling

Site Principal Investigator: Roshan George, MD and Margo Kamel, PhD

Study coordinator: Alexandria Wilkerson (404-727-6914)

 

Other active studies:

Childhood Nephrotic Syndrome Observational Study (CNOS)

Lupus Registry

LN Autoantibodies

Practice Patterns and Outcomes of ACTHar use in Children with Nephrotic Syndrome

 

Closed studies:

Executive Function in Children with Hypertension

Bovine Serum Albumin-Related Membranous Nephropathy

A Phase 3b, Multicenter, Open-label, Randomized Withdrawal Trial of the Effects of Titrated Oral SAMSCA® (Tolvaptan) on Serum Sodium, Pharmacokinetics, and Safety in Children and Adolescent Subjects Hospitalized With Euvolemic or Hypervolemic Hyponatremia" (OTSUKA)

A Phase 3b, Multicenter, Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Subjects With Euvolemic or Hypervolemic Hyponatremia Who Have Previously Participated in a Trial of Titrated Oral SAMSCA® (Tolvaptan)

Amgen Study 20140159: A Multicenter Single-arm Extension Study to characterize the Long-term Safety of Cinacalcet Hydrochloride in the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects With Chronic Kidney Disease on Dialysis.

Margret Kamel, PhD, CHES, CCRC, is the Associate Director of Research Projects for the Division of Pediatric Nephrology. She completed her BA from Rhodes College in Memphis, TN, her MSPH from Meharry Medical College in Nashville, TN, and her PhD from the University of Georgia in Athens, GA. 

Brian Lee is a Clinical Research Coordinator for the Division of Pediatric Nephrology. He completed his Bachelors of Science in Neuroscience & Behavioral Biology from Emory University in 2016. He first joined the division as a student intern in 2014 before transitioning into full-time employment soon after graduation. He serves as the lead coordinator for a variety of studies that examine glomerulonephritis, chronic kidney disease, kidney transplants, Lupus, and Alport Syndrome. Outside of work, Brian enjoys watching baseball, browsing through Reddit, and spending quality time with friends and family.

Helina Iyob-Tessema is a Clinical Research Coordinator for the Division of Pediatric Nephrology. She completed her Bachelors of Science in Anthropology and Human Biology with a minor in Chinese Studies from Emory University in 2016. She first joined the division as a student intern in 2014 before transitioning into full-time employment soon after graduation. She serves as the lead coordinator for a variety of studies that examine glomerulonephritis, cystinosis, chronic kidney disease, and kidney transplants. Outside of work, Helina enjoys cooking/baking, spending quality time with friends and family, as well as tutoring and mentoring students.

Segun Adeagbo is a Clinical Research Coordinator for the Division of Pediatric Nephrology. He completed his Bachelors of Science in Biology and Philosophy from Emory University in 2017. He first joined the division as a student intern in 2015 before transitioning into full-time employment soon after graduation. He serves as the lead coordinator for a variety of studies that examine chronic kidney disease and aHUS. Outside of work, Segun enjoys playing video games and watching anime. 

IROC

Recruitment Status: Enrolling

Site Principal Investigator: Rouba Garro, MD

 

Ninja

Recruitment Status: Enrolling

Site Principal Investigator: Stella Shin, MD

The Division of Pediatric Nephrology at Emory University offers a 3-year fellowship curriculum that combines dynamic clinical service, structured didactics, and mentored clinical or basic research. 

http://www.pediatrics.emory.edu/divisions/nephrology/fellow/index.html