drugset / Trial / NCT01452412
Alkali Therapy in Chronic Kidney Disease
Phase 2/3
Completed
149 enrolled
Albert Einstein College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Kidney disease is a common medical condition. Individuals with kidney disease develop a build-up of acid in their blood. This acid can affect their muscles, bones, glucose metabolism and kidneys. The investigators will test alkali treatment, to treat acid build-up, in a randomized placebo-controlled clinical trial to evaluate effects on muscles, bones, glucose metabolism and kidney.
Timeline
- Start
- 2011-10
- Primary completion
- 2016-08
- Completion
- 2016-08
Publications
- Brightwell CR, Kulkarni AS, Paredes W, Zhang K, Perkins JB, Gatlin KJ, Custodio M, Farooq H, Zaidi B, Pai R, Buttar RS, Tang Y, Melamed ML, Hostetter TH, Pessin JE, Hawkins M, Fry CS, Abramowitz MK. Muscle fibrosis and maladaptation occur progressively in CKD and are rescued by dialysis. JCI Insight. 2021 Dec 22;6(24):e150112. doi: 10.1172/jci.insight.150112.
- Melamed ML, Horwitz EJ, Dobre MA, Abramowitz MK, Zhang L, Lo Y, Mitch WE, Hostetter TH. Effects of Sodium Bicarbonate in CKD Stages 3 and 4: A Randomized, Placebo-Controlled, Multicenter Clinical Trial. Am J Kidney Dis. 2020 Feb;75(2):225-234. doi: 10.1053/j.ajkd.2019.07.016. Epub 2019 Nov 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sodium bicarbonate | Diagnostic / imaging agent | 0.4 meq | — |