Phosphate Lowering in CKD Trial

NCT02209636 ↗

Phase 4 Completed 66 enrolled VA Office of Research and Development

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The proposed research is a randomized-controlled trial to determine the effectiveness of reducing serum phosphorus using a phosphate binder, lanthanum carbonate, for improving the function of arteries in adults with moderate to severe chronic kidney disease (CKD). \[COMIRB 13-0328\] Additionally, it will determine phosphorus balance among adults with CKD and whether there is a difference in phosphorus balance after three months of treatment with lanthanum carbonate. \[COMIRB 15-0384\]

Timeline

Start: 2014-09-15
Primary completion: 2019-06-28
Completion: 2019-12-20

Outcome

Missed primary endpoint

paper FMDBA and cfPWV did not change from baseline in either group: FMDBA lanthanum 3.13%±2.87% to 2.73%±2.48% versus placebo 3.74%±2.86% to 3.09%±2.49% (P = 0.67); PMID 38781013 ↗

Publications

Jovanovich A, Struemph T, You Z, Wang W, Farmer-Bailey H, Bispham N, Levi M, Schwartz GG, Nowak KL, Chonchol M. Effect of Lanthanum Carbonate on Serum Phosphate, Oxidative Stress, and Vascular Dysfunction in CKD: A Mechanistic Randomized Controlled Trial. Kidney360. 2024 Jul 1;5(7):959-966. doi: 10.34067/KID.0000000000000465. Epub 2024 May 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lanthanum Carbonate	Other / unclassified	1500 mg	—
Subject	Lanthanum Carbonate	Other / unclassified	4500 mg	—
Background	Nitroglycerin	Unknown	—	Other
Background	Vitamin C	Other / unclassified	—	Intravenous