Abstract

This category A study was designed by Dr. Renlund, who then obtained support for the study from the SangStat Medical Corporation. Sang-35 is a new, generic formulation of cyclosporin that has previously been tested only in healthy volunteers and in a very small number of patients who have undergone renal transplant. The generic formulation appeared to be bioequivalent to Neoral. Dr. Renlund approached the SangStat Corporation with a protocol designed to test the efficacy of the new formulation in patients who have undergone cardiac transplantation. Dr. Renlund worked with the company and developed a mutually-agreeable protocol, which is now being carried out on the GCRC. The purpose of the study is to define the safety, tolerability, and pharmacokinetic equivalency of Sang-35 in """"""""healthy"""""""" heart transplant recipients. This is a two-component study. The first part is a double-blind, randomized, single-center (Utah), crossover pharmacokinetic evaluation. The second part is a parallel safety-tolerability study. An important cost saving might result if Sang-35 proved to be a bioequivalent formulation of cyclosporin. The drug has proven to be safe, and the efficacy portion of the study has not yet been completed. Preliminary results from the study will be presented at the American Society of Transplant Physicians to be held in May of 1999.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000064-36S1
Application #
6419487
Study Section
Project Start
1999-12-01
Project End
2001-02-28
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
36
Fiscal Year
2001
Total Cost
$248,088
Indirect Cost

  Institution

Name
University of Utah
Department
Type
DUNS #
City
Salt Lake City
State
UT
Country
United States
Zip Code
84112

  Publications

Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Di Fiore, Juliann M; Martin, Richard J; Li, Hong et al. (2017) Patterns of Oxygenation, Mortality, and Growth Status in the Surfactant Positive Pressure and Oxygen Trial Cohort. J Pediatr 186:49-56.e1
Adams, Ted D; Davidson, Lance E; Litwin, Sheldon E et al. (2017) Weight and Metabolic Outcomes 12 Years after Gastric Bypass. N Engl J Med 377:1143-1155
Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628
Archer, Stephanie Wilson; Carlo, Waldemar A; Truog, William E et al. (2016) Improving publication rates in a collaborative clinical trials research network. Semin Perinatol 40:410-417
Phelps, Dale L; Ward, Robert M; Williams, Rick L et al. (2016) Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants. Pediatr Res 80:209-17
Harper, Lorie M; Mele, Lisa; Landon, Mark B et al. (2016) Carpenter-Coustan Compared With National Diabetes Data Group Criteria for Diagnosing Gestational Diabetes. Obstet Gynecol 127:893-8
Bowles, Neil E; Jou, Chuanchau J; Arrington, Cammon B et al. (2015) Exome analysis of a family with Wolff-Parkinson-White syndrome identifies a novel disease locus. Am J Med Genet A 167A:2975-84
Priester, Tiffany; Ault, Travis G; Davidson, Lance et al. (2015) Coronary calcium scores 6 years after bariatric surgery. Obes Surg 25:90-6
Adams, T D; Hammoud, A O; Davidson, L E et al. (2015) Maternal and neonatal outcomes for pregnancies before and after gastric bypass surgery. Int J Obes (Lond) 39:686-94

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