drugset / Trial / NCT06890143
The Efficacy and Safety of Dapagliflozin in the Treatment of Hereditary Kidney Disease With Proteinuria in Children
Phase 3
Recruiting
44 enrolled
Children's Hospital of Fudan University
Children's Hospital of Nanjing Medical University · collabChildren's Hospital of The Capital Institute of Pediatrics · collabFirst Affiliated Hospital, Sun Yat-Sen University · collabFirst People's Hospital of Urumqi · collabGuangzhou Women and Children's Medical Center · collabGuiyang Maternity and Child Health Care Hospital · collabKunming Children's Hospital · collabMaternal and Child Health Care Hospital of Hainan Province · collabMaternal and Child Health Hospital of Guangxi Zhuang Autonomous Region · collabSecond Affiliated Hospital of Wenzhou Medical University · collabShandong Provincial Hospital · collabThe Children's Hospital of Zhejiang University School of Medicine · collabThe First Affiliated Hospital of Henan University of Traditional Chinese Medicine · collabThe Second Hospital of Hebei Medical University · collabWuhan Children's Hospital · collabWuxi Women's & Children's Hospital · collabXiamen Women's and Children's Hospital · collabXian Children's Hospital · collabXuzhou Children Hospital · collabZhengzhou Children's Hospital, China · collab
RandomizedCrossoverSingle-blindTreatment
Summary
This study is a multicenter, randomized controlled crossover trial aimed to evaluate the efficacy and safety of dapagliflozin in the treatment of hereditary kidney disease with proteinuria in children
Timeline
- Start
- 2025-03-22
- Primary completion
- 2026-12-31
- Completion
- 2027-03-31
Publications
- Background Chinese Preventive Medicine Association for Kidney Disease. [Guidelines for the early evaluation and management of chronic kidney disease in China]. Zhonghua Nei Ke Za Zhi. 2023 Aug 1;62(8):902-930. doi: 10.3760/cma.j.cn112138-20221013-00755. Chinese.
- Background The Expert Group of Chinese Expert Consensus on the Clinical Application of Sodium-glucose Cotransporter 2 Inhibitors in Patients with Chronic Kidney Disease. Chinese expert consensus on the clinical application of sodium-glucose cotransporter 2 inhibitors in patients with chronic kidney disease. Chin Med J (Engl). 2024 Jun 5;137(11):1264-1266. doi: 10.1097/CM9.0000000000003145. Epub 2024 May 13. No abstract available.
- Background O'Hara DV, Lam CSP, McMurray JJV, Yi TW, Hocking S, Dawson J, Raichand S, Januszewski AS, Jardine MJ. Applications of SGLT2 inhibitors beyond glycaemic control. Nat Rev Nephrol. 2024 Aug;20(8):513-529. doi: 10.1038/s41581-024-00836-y. Epub 2024 Apr 26.
- Background Koppe L, Fouque D. The Role for Protein Restriction in Addition to Renin-Angiotensin-Aldosterone System Inhibitors in the Management of CKD. Am J Kidney Dis. 2019 Feb;73(2):248-257. doi: 10.1053/j.ajkd.2018.06.016. Epub 2018 Aug 24.
- Background Herrington WG, Preiss D, Haynes R, von Eynatten M, Staplin N, Hauske SJ, George JT, Green JB, Landray MJ, Baigent C, Wanner C. The potential for improving cardio-renal outcomes by sodium-glucose co-transporter-2 inhibition in people with chronic kidney disease: a rationale for the EMPA-KIDNEY study. Clin Kidney J. 2018 Dec;11(6):749-761. doi: 10.1093/ckj/sfy090. Epub 2018 Oct 25.
- Background Cherney DZI, Dekkers CCJ, Barbour SJ, Cattran D, Abdul Gafor AH, Greasley PJ, Laverman GD, Lim SK, Di Tanna GL, Reich HN, Vervloet MG, Wong MG, Gansevoort RT, Heerspink HJL; DIAMOND investigators. Effects of the SGLT2 inhibitor dapagliflozin on proteinuria in non-diabetic patients with chronic kidney disease (DIAMOND): a randomised, double-blind, crossover trial. Lancet Diabetes Endocrinol. 2020 Jul;8(7):582-593. doi: 10.1016/S2213-8587(20)30162-5.
- Background Heerspink HJL, Cherney D, Postmus D, Stefansson BV, Chertow GM, Dwyer JP, Greene T, Kosiborod M, Langkilde AM, McMurray JJV, Correa-Rotter R, Rossing P, Sjostrom CD, Toto RD, Wheeler DC; DAPA-CKD Trial Committees and Investigators. A pre-specified analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial on the incidence of abrupt declines in kidney function. Kidney Int. 2022 Jan;101(1):174-184. doi: 10.1016/j.kint.2021.09.005. Epub 2021 Sep 22.
- Results Scheen AJ. Sodium-glucose cotransporter type 2 inhibitors for the treatment of type 2 diabetes mellitus. Nat Rev Endocrinol. 2020 Oct;16(10):556-577. doi: 10.1038/s41574-020-0392-2. Epub 2020 Aug 27.
- Results Ravani P, Rossi R, Bonanni A, Quinn RR, Sica F, Bodria M, Pasini A, Montini G, Edefonti A, Belingheri M, De Giovanni D, Barbano G, Degl'Innocenti L, Scolari F, Murer L, Reiser J, Fornoni A, Ghiggeri GM. Rituximab in Children with Steroid-Dependent Nephrotic Syndrome: A Multicenter, Open-Label, Noninferiority, Randomized Controlled Trial. J Am Soc Nephrol. 2015 Sep;26(9):2259-66. doi: 10.1681/ASN.2014080799. Epub 2015 Jan 15.
- Results Heerspink HJL, Jongs N, Chertow GM, Langkilde AM, McMurray JJV, Correa-Rotter R, Rossing P, Sjostrom CD, Stefansson BV, Toto RD, Wheeler DC, Greene T; DAPA-CKD Trial Committees and Investigators. Effect of dapagliflozin on the rate of decline in kidney function in patients with chronic kidney disease with and without type 2 diabetes: a prespecified analysis from the DAPA-CKD trial. Lancet Diabetes Endocrinol. 2021 Nov;9(11):743-754. doi: 10.1016/S2213-8587(21)00242-4. Epub 2021 Oct 4.
- Results Waijer SW, Vart P, Cherney DZI, Chertow GM, Jongs N, Langkilde AM, Mann JFE, Mosenzon O, McMurray JJV, Rossing P, Correa-Rotter R, Stefansson BV, Toto RD, Wheeler DC, Heerspink HJL. Effect of dapagliflozin on kidney and cardiovascular outcomes by baseline KDIGO risk categories: a post hoc analysis of the DAPA-CKD trial. Diabetologia. 2022 Jul;65(7):1085-1097. doi: 10.1007/s00125-022-05694-6. Epub 2022 Apr 21.
- Results Jongs N, Greene T, Chertow GM, McMurray JJV, Langkilde AM, Correa-Rotter R, Rossing P, Sjostrom CD, Stefansson BV, Toto RD, Wheeler DC, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Effect of dapagliflozin on urinary albumin excretion in patients with chronic kidney disease with and without type 2 diabetes: a prespecified analysis from the DAPA-CKD trial. Lancet Diabetes Endocrinol. 2021 Nov;9(11):755-766. doi: 10.1016/S2213-8587(21)00243-6. Epub 2021 Oct 4.
- Results HEERSPINK H J L, STEFáNSSON B V, CORREA-ROTTER R, et al. Dapagliflozin in Patients with Chronic Kidney Disease
- Results Heerspink HJL, Stefansson BV, Chertow GM, Correa-Rotter R, Greene T, Hou FF, Lindberg M, McMurray J, Rossing P, Toto R, Langkilde AM, Wheeler DC; DAPA-CKD Investigators. Rationale and protocol of the Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial. Nephrol Dial Transplant. 2020 Feb 1;35(2):274-282. doi: 10.1093/ndt/gfz290.
- Results Rajasekeran H, Reich HN, Hladunewich MA, Cattran D, Lovshin JA, Lytvyn Y, Bjornstad P, Lai V, Tse J, Cham L, Majumder S, Bowskill BB, Kabir MG, Advani SL, Gibson IW, Sood MM, Advani A, Cherney DZI. Dapagliflozin in focal segmental glomerulosclerosis: a combined human-rodent pilot study. Am J Physiol Renal Physiol. 2018 Mar 1;314(3):F412-F422. doi: 10.1152/ajprenal.00445.2017. Epub 2017 Nov 15.
- Results Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Erondu N, Shaw W, Barrett TD, Weidner-Wells M, Deng H, Matthews DR, Neal B. Canagliflozin and renal outcomes in type 2 diabetes: results from the CANVAS Program randomised clinical trials. Lancet Diabetes Endocrinol. 2018 Sep;6(9):691-704. doi: 10.1016/S2213-8587(18)30141-4. Epub 2018 Jun 21.
- Results Kadowaki T, Nangaku M, Hantel S, Okamura T, von Eynatten M, Wanner C, Koitka-Weber A. Empagliflozin and kidney outcomes in Asian patients with type 2 diabetes and established cardiovascular disease: Results from the EMPA-REG OUTCOME(R) trial. J Diabetes Investig. 2019 May;10(3):760-770. doi: 10.1111/jdi.12971. Epub 2019 Jan 7.
- Results Jardine MJ, Mahaffey KW, Neal B, Agarwal R, Bakris GL, Brenner BM, Bull S, Cannon CP, Charytan DM, de Zeeuw D, Edwards R, Greene T, Heerspink HJL, Levin A, Pollock C, Wheeler DC, Xie J, Zhang H, Zinman B, Desai M, Perkovic V; CREDENCE study investigators. The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Study Rationale, Design, and Baseline Characteristics. Am J Nephrol. 2017 Dec 13;46(6):462-472. doi: 10.1159/000484633. Online ahead of print.
- Results Heerspink HJ, Desai M, Jardine M, Balis D, Meininger G, Perkovic V. Canagliflozin Slows Progression of Renal Function Decline Independently of Glycemic Effects. J Am Soc Nephrol. 2017 Jan;28(1):368-375. doi: 10.1681/ASN.2016030278. Epub 2016 Aug 18.
- Results Tirucherai GS, LaCreta F, Ismat FA, Tang W, Boulton DW. Pharmacokinetics and pharmacodynamics of dapagliflozin in children and adolescents with type 2 diabetes mellitus. Diabetes Obes Metab. 2016 Jul;18(7):678-84. doi: 10.1111/dom.12638.
- Results Dekkers CCJ, Gansevoort RT, Heerspink HJL. New Diabetes Therapies and Diabetic Kidney Disease Progression: the Role of SGLT-2 Inhibitors. Curr Diab Rep. 2018 Mar 27;18(5):27. doi: 10.1007/s11892-018-0992-6.
- Results Vallon V, Thomson SC. Targeting renal glucose reabsorption to treat hyperglycaemia: the pleiotropic effects of SGLT2 inhibition. Diabetologia. 2017 Feb;60(2):215-225. doi: 10.1007/s00125-016-4157-3. Epub 2016 Nov 22.
- Results Petrovic D, Stojimirovic B. Proteinuria as a risk factor for the progression of chronic renal disease. Vojnosanit Pregl. 2008 Jul;65(7):552-8. doi: 10.2298/vsp0807552p. No abstract available.
- Results Jafar TH, Stark PC, Schmid CH, Landa M, Maschio G, Marcantoni C, de Jong PE, de Zeeuw D, Shahinfar S, Ruggenenti P, Remuzzi G, Levey AS; AIPRD Study Group. Angiotensin-Converting Enzymne Inhibition and Progression of Renal Disease. Proteinuria as a modifiable risk factor for the progression of non-diabetic renal disease. Kidney Int. 2001 Sep;60(3):1131-40. doi: 10.1046/j.1523-1755.2001.0600031131.x.
- Results Leung AK, Wong AH, Barg SS. Proteinuria in Children: Evaluation and Differential Diagnosis. Am Fam Physician. 2017 Feb 15;95(4):248-254.
- Results Sumida K, Molnar MZ, Potukuchi PK, George K, Thomas F, Lu JL, Yamagata K, Kalantar-Zadeh K, Kovesdy CP. Changes in Albuminuria and Subsequent Risk of Incident Kidney Disease. Clin J Am Soc Nephrol. 2017 Dec 7;12(12):1941-1949. doi: 10.2215/CJN.02720317. Epub 2017 Sep 11.
- Results Romagnani P, Remuzzi G, Glassock R, Levin A, Jager KJ, Tonelli M, Massy Z, Wanner C, Anders HJ. Chronic kidney disease. Nat Rev Dis Primers. 2017 Nov 23;3:17088. doi: 10.1038/nrdp.2017.88.
- Results Yang CW, Harris DCH, Luyckx VA, Nangaku M, Hou FF, Garcia Garcia G, Abu-Aisha H, Niang A, Sola L, Bunnag S, Eiam-Ong S, Tungsanga K, Richards M, Richards N, Goh BL, Dreyer G, Evans R, Mzingajira H, Twahir A, McCulloch MI, Ahn C, Osafo C, Hsu HH, Barnieh L, Donner JA, Tonelli M. Global case studies for chronic kidney disease/end-stage kidney disease care. Kidney Int Suppl (2011). 2020 Mar;10(1):e24-e48. doi: 10.1016/j.kisu.2019.11.010. Epub 2020 Feb 19.
- Results Zhang L, Wang F, Wang L, Wang W, Liu B, Liu J, Chen M, He Q, Liao Y, Yu X, Chen N, Zhang JE, Hu Z, Liu F, Hong D, Ma L, Liu H, Zhou X, Chen J, Pan L, Chen W, Wang W, Li X, Wang H. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012 Mar 3;379(9818):815-22. doi: 10.1016/S0140-6736(12)60033-6.
- Zhang W, Dou Y, Liu J, Liu T, Yan W, Shen Q, Xu H, Zhai Y. Effects and safety of dapagliflozin in paediatric hereditary kidney disease: protocol for a multicentric, prospective, open and randomised crossover study (DAPA-PedHKD). BMJ Open. 2025 Dec 14;15(12):e109833. doi: 10.1136/bmjopen-2025-109833.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 5 mg | Oral |
| Subject | Dapagliflozin | Small molecule | 10 mg | Oral |