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: Enrollment Closed

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

 

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

 

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

 

A Phase 3, Open-Label, Multicenter Study of ALXN1210 In Children and Adolescents with Atypical Hemolytic-Uremic Syndrome (aHUS)

This study is to assess the efficacy of ALXN1210 in complement inhibitor treatment-naive pediatric patients with aHUS. ALXN1210, an analog to Solaris, will be administered through venous infusion every 8 weeks. 

Study information: https://clinicaltrials.gov/ct2/show/NCT03131219

Recruitment status: Enrolling

Site Principal Investigator: Larry Greenbaum, MD, PhD

Study Coordinator: Segun Adeagbo (404) 727-0851

 

ACTH for Drug Resistant Nephrotic Syndrome in Children (ADRENL)

This study will see if Purified Porcine ACTH (ACTHAR) is an effective therapy for inducing remission of proteinuria in children with steroid resistant nephrotic syndrome. Participants must have had no success with their therapy to qualify. 

Study information: https://clinicaltrials.gov/ct2/show/NCT03408405

Recruitment status: Enrolling

Site Principal Investigator: Larry Greenbaum, MD, PhD

Study 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:

KiD-B: Pediatric Nephrology Biorepository

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

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

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

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.