Nephrology and Renal Disease Clinical Trial Research Experience

Partner with a Specialty Team in Nephrology and Renal Disease Clinical Research

Clinical studies in renal diseases present unique challenges. One of the biggest obstacles—identifying and recruiting patients— requires trusted, long-term relationships with sites and KOLs around the world. It also requires a team of medical, regulatory and operational experts who can drive strategy and efficiency that will accelerate your product’s development.

A CRO with Deep Renal Disease and Nephrology Experience

Medpace has global experience conducting trials for a variety of kidney-related diseases from early through late phase. An international network of nephrology sites and strong relationships with KOLs streamlines the development process and is enhanced by our experience and history in recruiting hard to enroll patient populations.

Our scientifically-driven approach to clinical development provides you the advantage of early and ongoing insight and guidance from therapeutic experts throughout trial design and execution. Understanding that renal patients often have comorbidities such as cardiovascular disease, diabetes, and obesity, our nephrology and renal disease team works in collaboration with our in-house experts in these associated diseases. Our model embeds scientific expertise throughout your studies, providing greater depth and the ability to tackle complex and challenging diseases.

A Depth of Experience across Renal Disease and Nephrology Indications

Renal insufficiency and failure
Genetic or Rare kidney diseases including Vasculitis and Enteric Hyperoxaluria
Nephrolithiasis
Glomerulonephritis associated with ANCA vasculitis, IgA nephropathy, membranous nephropathy, C3 glomerulonephritis and focal segmental Glomerulosclerosis
Bone & Mineral Metabolism (including hyperphosphatemia)
Metabolic acidosis/alkalosis, electrolyte Disorders
Chronic Kidney Disease (CKD) and End Stage Renal Disease (ESRD) including dialytic therapies
Diabetic Nephropathy
Anemia/CKD

The Medpace Difference for Renal Disease and Nephrology Studies

Medpace conducts trials in renally-impaired patients, including patients currently undergoing dialysis, and in patients suffering from other chronic and rare kidney diseases.

Sponsors conducting clinical research in nephrology and renal diseases benefit from:

In-house board-certified nephrologists with strong backgrounds in academic and clinical practice and pharmaceutical development
Experienced clinical practitioners provide therapy area training to site staff and an understanding of clinical settings
Global experience conducting Phase I-IV renal disease clinical trials spanning adult and pediatric populations
Strong relationships with successful, experienced investigative sites which regularly participate and successfully enroll nephrology studies
A seasoned clinical operations staff with specific experience in conducting renal disease trials
Thorough understanding of the complex conditions that cause CKD, as well as the medical complications experienced by patients with CKD and ESRD (end-stage renal disease)
Cross-over medical expertise in related therapeutic areas including metabolic, cardiovascular, and autoimmune
Specialized expertise in rare disease and orphan indications
Integrated core imaging, ECG and central laboratory services

Global Testing from our Integrated Central Laboratories

Medpace’s central laboratories have unmatched experience and expertise to seamlessly support nephrology testing.

Relevant sample areas include:

Chronic Kidney Disease (CKD)
Acute Kidney Injury
Autoimmune Disorders
Inflammation
Lipids
Nonalcoholic Steatohepatitis (NASH)
Endocrine disorders
Obesity

Key staff involves doctors, managers, and technologists with considerable expertise in the area of central laboratory operations for the pharmaceutical industry and federally funded programs, from discovery and proof of concept through large, long term global trials.

Four global, harmonized, Medpace owned and operated, purpose built central lab locations: US, Belgium, Singapore, China
A global team of hands-on laboratory PhDs who actively engage with your study team to identify and validate additional biomarkers to support your study program
Experienced and stable project management team
Medpace is continually validating new biomarkers to support our sponsors’ programs

Our extensive test menu of validated biomarkers and tests include:

Albumin
ANA
Beta 2 Microglobulin
Calbindin
Ceruloplasmin
Clusterin
Complement factors
Creatinine
Cystatin C
Epidermal Growth Factor (EGF)
Fibroblast Growth Factor 23, c-terminal (FGF-23)
Immunoglobulins
Interleukins
Kidney Injury Molecule 1 (KIM-1)
Myeloperoxidase (MPO)
N-Acetyl-beta Glucosaminidase (NAG)
Neutrophil gelatinase-associated lipocalin (NGAL)
Osmolality
Osteoactivin
Podcalyxin
Proteinase 3 (PR3)
Serum Electrophoresi (SPEP)
Serum Immunofixation
Transforming Growth Factor Beta 1 (TGF-β1)
Trefoil Factor 3
Tumor Necrosis Factors (TNFs)
Urinalysis (including 24 hour collections)
Urine Electrophoresis (UPEP)
Urine Immunofixation
Vascular Endothelial – Growth Factor (VEGF)

Core Imaging and Cardiovascular Safety: Integrated Expertise and Efficiency

Medpace Core Laboratories has extensive clinical trial experience with complex CT, MR, US and DXA assessments—and their respective analysis and quality control checks. With highly experienced and knowledgeable leadership by physicians and scientists, Medpace offers significant advantages in experience, systems, data integrity, and compliance.

Board-certified radiologists, nephrologists and endocrinologists
Widespread knowledge in qualifying sites with customized and advanced data and acquisition protocols
Specialized project managers experienced in utilizing these modalities specifically for kidney assessment
Leader in imaging for endocrine and metabolic clinical trials, closely linked to nephrology studies
Centralized ECG machines and analysis to provide an electronic cardiac safety database.