We specialize in the unique challenges associated with nephrology populations,

from mild to moderate renal impairment to dialysis, with an emphasis on chronic kidney disease.

Nephrology is a diverse area of research encompassing several diseases that affect renal function, either as a primary diagnosis or as a secondary complication from an underlying problem. CTI has consistently worked in this area for 20 years. Past and ongoing trials have ranged from small first-in-human trials to large multi-national registries. Our Medical Directors, including a former transplant surgeon, work closely with the rest of our organization so that project teams are familiar with renal diseases and associated complications. We specialize in the unique challenges associated with nephrology populations, from mild to moderate renal impairment to dialysis, with an emphasis on chronic kidney disease. We attend industry meetings and are members of many nephrology societies, including the American Society for Nephrology (ASN), American Society of Pediatric Nephrology (ASPN), and the International Society of Nephrology (ISN).

We offer our sponsors:

  • Medical affairs team that includes a former transplant surgeon 
  • A deep therapeutic expertise, as well as relationships with academic and community medical centers and dialysis units
  • Insight into clinical program planning, trial design/execution, and development of creative solutions for patient identification, recruitment, and retention challenges
  • An employee turnover rate less than half of the reported industry average, resulting in team continuity
  • Experience with first-in-human, first-in-class, and first-in-patient trials
  • Personal relationships with key investigators and site personnel
  • Executive management involvement on every project
  • CTI studies regularly exceed industry standards for enrollment, despite challenging patient populations
  • A proven track record of success with more than 100 drug and device approvals
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Approvals

CTI has been involved in multiple programs that led to FDA and EMA breakthroughs, including therapy for the prophylaxis of organ rejection in kidney transplant patients and biologic for immunosuppression in de novo kidney transplant recipients.

Some of our adult and pediatric experience includes:

  • Acute kidney injury (AKI)
  • Alport syndrome
  • Atypical hemolytic uremic syndrome (aHUS)
  • Chronic kidney disease (CKD)
  • Chronic allograft injury
  • Chronic hepatitis C virus (HCV)
  • Contrast-induced nephropathy (CIN)
  • Cystinosis
  • Delayed graft function (DGF)
  • Diabetes-related renal disease
  • Dialysis/Hemodialysis vascular access
  • End stage renal disease
  • Ischemia reperfusion injury (IRI)
  • Kidney transplant
  • Organ rejection (acute cellular rejection [ACR] and antibody mediated rejection [AMR])
  • Renal fibrosis
  • Renal function