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Table 3 Incidence of serum creatinine elevations during the extension study

From: Efficacy and safety during extended treatment of lesinurad in combination with febuxostat in patients with tophaceous gout: CRYSTAL extension study

Serum creatinine criterion 200CONT
(N = 64)
n (%)
200CROSS
(N = 33)
n (%)
400CONT
(N = 65)
n (%)
400CROSS
(N = 34)
n (%)
 
sCr elevation ≥ 1.5× lesinurad baselinea  
 Number of patients with elevation 9 (14.1) 6 (18.2) 14 (21.5) 7 (20.6)  
 Number of elevations 12 7 15 8  
 Number (%) resolutionsb 10/12 (83.3) 4/7 (57.1) 14/15 (93.3) 8/8 (100)  
 Number (%) resolutions after interruption of study medication 3/12 (25.0) 0/7 (0) 5/15 (33.3) 0/8 (0)  
 Number (%) resolutions without interruption of study medication 7/12 (58.3) 4/7 (57.1) 9/15 (60.0) 8/8 (100)  
 Number (%) unresolved at last visit 2/12 (16.7) 3/7 (42.9) 1/15 (6.7) 0/8 (0)  
sCr elevation ≥ 2.0× lesinurad baselinea  
 Number of patients with elevation 4 (6.3) 0 (0) 2 (3.1) 4 (11.8)  
 Number of elevations 4 0 2 5  
 Number (%) resolutionsb 4/4 (100) 0/0 (0) 2/2 (100) 5/5 (100)  
 Number (%) resolutions after interruption of study medication 3/4 (75.3) 0/0 (0) 1/2 (50.0) 0/5 (0)  
 Number (%) resolutions without interruption of study medication 1/4 (25.0) 0/0 (0) 1/2 (50.0) 5/5 (100)  
 Number (%) unresolved at last visit 0/4 (0) 0/0 (0) 0/2 (0) 0/5 (0)  
  1. Abbreviations: CONT Continuation of lesinurad treatment, CROSS Crossover from core study placebo to lesinurad treatment, sCr serum creatinine
  2. aLesinurad baseline is before starting lesinurad therapy; for CONT groups, at the start of the core study; for CROSS groups, at the start of the extension study
  3. bResolution defined as sCr value ≤ 1.2× baseline following an elevation