Nephrology and Renal Disease
In Depth Clinical Trial Expertise in Nephrology and Renal Disease
PPD has significant experience in the design, planning and execution of Phase I-IV full service global trials in nephrology and renal diseases. Our nephrology team has in-depth insight into the scientific methodology, competitive research landscape and key regulatory drivers to move product development forward quickly.
PPD’s nephrology/renal disease global investigator network consists of nephrologists, critical care specialists, endocrinologists, internists and key opinion leaders, as well as a broad number of academic sites and dialysis centers which enable us to provide robust feasibility and consulting services across a wide spectrum of renal disease indications.
PPD recognizes that patients with renal disease often face the burden of living with other comorbidities that take a toll on their quality of life and life expectancy. We have developed a comprehensive team of medical experts across varying therapeutic areas including metabolic, cardiovascular, and autoimmune to ensure wholistic patient care. This integrated team of medical experts provide our clients with sound strategic guidance to drive efficient and effective clinical trials that address the challenges associated with renal diseases.
Our comprehensive renal and nephrology clinical study experience spans a broad range of indications including:
- Chronic renal disease and end stage renal disease
- Diabetic nephropathy
- Vasculitis (i.e., SLE)
- Acute kidney injury
- Glomerulonephritis (i.e., IgA nephropathy and focal glomerulosclerosis)
- Kidney transplantation
- Polycystic kidney disease
- Alport syndrome
Additionally, our team has experience working with pediatric and rare renal conditions, having conducted 16 rare renal disease studies over the past five years.
Advancing Nephrology and Renal Disease Clinical Research in Peri-and Post- Approval Settings
Evidera, PPD’s business specializing in evidence, value and access, brings extensive experience across the spectrum of nephrology indications, including chronic kidney disease, diabetic kidney disease, end stage renal disease, renal transplants and renal cell carcinoma. We have completed approximately 150 engagements in nephrology over the past five years across our service offerings and in markets around the globe. This work also includes 22 real-world evidence studies. Our work has addressed a broad range of issues such as treatment sequencing, humanistic and economic burden of disease and epidemiological and market access research. We have also published 70 papers in peer-reviewed and non-peer reviewed journals, such as Immunotherapy, Transplantation, Clinical Therapeutics, the International Journal of Nephrology and the Journal of Clinical Pharmacology.
Sponsors conducting clinical research in Nephrology and Renal diseases benefit from:
- Experienced global team consisting of three in-house, board-certified nephrologists with over 30 years of experience in clinical drug development, responsible for leading several drugs from early phase development through product launch.
- Expertise in conducting pediatric nephrology and rare renal disease studies.
- Established relationships with experienced investigative sites, key opinion leaders and partnership with top tier large dialysis organizations including Fresenius-Frenova.
- Integrated Central Laboratory which offers a complete menu of global testing options that delivers real-time integrated data to help clients make better and faster decisions.