Journal article
Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes
American journal of transplantation, Vol.21(4), pp.1477-1492
04/2021
DOI: 10.1111/ajt.16174
PMCID: PMC9074710
PMID: 32627352
Abstract
Allogeneic islet transplant offers a minimally invasive option for β cell replacement in the treatment of type 1 diabetes (T1D). The CIT consortium trial of purified human pancreatic islets (PHPI) in patients with T1D after kidney transplant (CIT06), a National Institutes of Health-sponsored phase 3, prospective, open-label, single-arm pivotal trial of PHPI, was conducted in 24 patients with impaired awareness of hypoglycemia while receiving intensive insulin therapy. PHPI were manufactured using standardized processes. PHPI transplantation was effective with 62.5% of patients achieving the primary endpoint of freedom from severe hypoglycemic events and HbA
≤ 6.5% or reduced by ≥ 1 percentage point at 1 year posttransplant. Median HbA
declined from 8.1% before to 6.0% at 1 year and 6.3% at 2 and 3 years following transplant (P < .001 for all vs baseline), with related improvements in hypoglycemia awareness and glucose variability. The improved metabolic control was associated with better health-related and diabetes-related quality of life. The procedure was safe and kidney allograft function remained stable after 3 years. These results add to evidence establishing allogeneic islet transplant as a safe and effective treatment for patients with T1D and unstable glucose control despite intensive insulin treatment, supporting the indication for PHPI in the post-renal transplant setting.
Details
- Title: Subtitle
- Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes
- Creators
- James F Markmann - Massachusetts General HospitalMichael R Rickels - University of PennsylvaniaThomas L Eggerman - National Institute of Diabetes and Digestive and Kidney DiseasesNancy D Bridges - National Institute of Allergy and Infectious DiseasesDavid E Lafontant - University of IowaJulie Qidwai - University of IowaEric Foster - Ferring PharmaceuticalsWilliam R Clarke - University of IowaMalek Kamoun - University of PennsylvaniaRodolfo Alejandro - University of MiamiMelena D Bellin - University of MinnesotaKathryn Chaloner - University of IowaChristine W Czarniecki - National Institute of Allergy and Infectious DiseasesJulia S Goldstein - National Institute of Allergy and Infectious DiseasesBernhard J Hering - University of MinnesotaLawrence G Hunsicker - University of IowaDixon B Kaufman - University of Wisconsin–MadisonOlle Korsgren - Uppsala UniversityChristian P Larsen - Emory UniversityXunrong Luo - Duke UniversityAli Naji - University of PennsylvaniaJosé Oberholzer - University of Illinois at ChicagoAndrew M Posselt - University of California, San FranciscoCamillo Ricordi - University of MiamiPeter A Senior - University of AlbertaA M James Shapiro - University of AlbertaPeter G Stock - University of California, San FranciscoNicole A Turgeon - The University of Texas at Austin
- Resource Type
- Journal article
- Publication Details
- American journal of transplantation, Vol.21(4), pp.1477-1492
- DOI
- 10.1111/ajt.16174
- PMID
- 32627352
- PMCID
- PMC9074710
- ISSN
- 1600-6135
- eISSN
- 1600-6143
- Grant note
- UL1 TR000150 / NCATS NIH HHS UL1TR000454 / Emory University UL1 RR025741 / NCRR NIH HHS U01 DK070430 / NIDDK NIH HHS 5U01DK070431 / University of Illinois at Chicago U01 AI065192 / NIAID NIH HHS UL1TR000003 / University of Pennsylvania UL1 TR000004 / NCATS NIH HHS U01AI089317 / Emory University U01AI065193 / University of Minnesota U01AI089316 / Northwestern University U01 DK085531 / NIDDK NIH HHS U01 AI065191 / NIAID NIH HHS U01AI065191 / University of Alberta U01 AI089316 / NIAID NIH HHS UL1TR000460 / University of Miami UL1TR000114 / University of Minnesota U01 AI089317 / NIAID NIH HHS UL1TR000150 / Northwestern University UL1 TR000454 / NCATS NIH HHS U01 AI065193 / NIAID NIH HHS UL1RR025741 / Northwestern University U01AI065192 / Uppsala Universitet M01 RR000400 / NCRR NIH HHS UL1 TR000050 / NCATS NIH HHS UL1 TR000114 / NCATS NIH HHS UL1TR000050 / University of Illinois at Chicago U01 DK070431 / NIDDK NIH HHS M01-RR00040 / University of Pennsylvania U01DK070430 / University of Pennsylvania U01 DK070460 / NIDDK NIH HHS M01 RR000040 / NCRR NIH HHS U01DK085531 / University of California, San Francisco UL1TR000004 / University of California, San Francisco U01DK070460 / University of Miami M01-RR000400 / University of Minnesota UL1 TR000460 / NCATS NIH HHS UL1 TR000003 / NCATS NIH HHS
- Language
- English
- Date published
- 04/2021
- Academic Unit
- Biostatistics; Nephrology; Internal Medicine
- Record Identifier
- 9984364394802771
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