Nephrology Clinical Trials

Chronic Kidney Disease (CKD) devastates millions of people’s lives every year. Our board-certified nephrologist and other specialists that make up the PharmaNet nephrology team have significant hands-on experience, including studies of factors influencing the morbidity and mortality of patients on hemodialysis, studies of treatments for hypertension, and investigations into glomerular nephritis.

Our strong clinical relationships with leading nephrology centers and specialists means PharmaNet’s nephrology team has access to specialized patient populations, including renal transplants, ESRD and pre-ESRD, CKD, and patients on hemodialysis and peritoneal dialysis.

PharmaNet has successfully conducted more than 12 clinical studies in chronic kidney disease (CKD) in the past several years, involving more than 10,000 patients, both in the dialysis and pre-dialysis populations. Several of these studies have been large international pivotal trials assessing definitive clinical endpoints, involving several hundred to over 1,000 patients/study. Accordingly, PharmaNet has developed a large database of nephrologists/renal specialists, the United States, Canada, South America, Central America, and Western and Eastern Europe, including Russia.

In addition, PharmaNet has conducted more than 15 studies in urologic indications in over 15,000 patients ranging from BPH to erectile dysfunction. We also collaborate with our oncology therapeutic area as needed to deal with renal and urologic cancers.

PharmaNet offers a comprehensive range of services for defining your drug development plan and managing the clinical trials. We can help design a regulatory strategy, meet with health authorities, and gain agreement on pivotal study design that will lead to a marketing agreement.

Our therapeutic insight makes PharmaNet the ideal partner to provide customized development solutions for your challenges:

  • We have experience in dealing with academic nephrology centers and corporate dialysis facilities.
  • We collaborate with renal opinion leaders, academic institutions, and ancillary service vendors.
  • Our teams work fluidly with Data Safety and Monitoring Committees and Clinical Endpoint Committees, which are often part of pivotal CKD programs, and continuously measure the quality of the endpoints and the efficiency of the process.

At the onset of your program, PharmaNet can identify renal investigators from our extensive global database of experienced, qualified, and motivated sites. Once selected, we contact the study centers, ensuring a timely start, effective recruitment, and continued retention of study subjects for your trials. We work with you to identify study specific risks and develop program contingencies.

Once the study is launched, the program is monitored by experienced clinical research associates. Project managers and medical monitors also provide oversight and smoothly navigate the program execution.

Our experience includes:

  • Mitigation of CKD progression
  • Hyperphosphatemia and secondary hyperparathyroidism
  • Anemia of CKD therapies • Nephrolithiasis
  • Diabetic nephropathy
  • Biosimilar drug development
  • Benign prostatic hypertrophy (BPH)
  • Bladder disorders
  • Impotence and erectile dysfunction

Therapeutic Expertise Brochure

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