Abstract: FR-PO880
Wide Fluctuation in Serum Creatinine Is Observed in Patient with Lupus Nephritis in Remission
Session Information
- Glomerular Diseases: Membranous Nephropathy, SLE, Complement
November 08, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1203 Glomerular Diseases: Clinical, Outcomes, and Trials
Authors
- Almaani, Salem, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
- Bhatt, Udayan Y., The Ohio State University, Dublin, Ohio, United States
- Solomons, Neil, Aurinia Pharmaceuticals, Victoria, British Columbia, Canada
- Rovin, Brad H., Ohio State University Wexner Medical Center, Columbus, Ohio, United States
Background
Clinical trials in lupus nephritis (LN) typically base remission on proteinuria and the relative change in serum creatinine (sCr) compared to baseline. These sCr cutoffs have been arbitrary, however we observe considerable fluctuation of sCr levels in clinical practice. This study was undertaken to assess the variability of sCr in stable, non-flaring LN patients.
Methods
Patient-level clinical data from patients enrolled in the ALMS, MAINTAIN, and ELNT trials who had ≥3 consecutive sCr measurements while in remission (uPCR ≤0.5g/mg) were used. Patients were split into a group having at least 1 sCr measurement >115% of baseline (fluctuators) and a group with no sCr measurements >115% of baseline (non-fluctuators). Disease characteristics and demographics were compared using ANOVA and logistic regression as appropriate.
Results
Changes in sCr over time are depicted in the figure. Group characteristics are described in the table. In the fluctuator group, 33%, 20%, and 12% of each patient’s creatinine measurements were >115%, 120%, and 125% above their baseline respectively. There was no significance difference between the two groups according to sex, race, C3 levels, hematuria, or ISN/RPS class. Univariate analysis revealed that older age and lower sCr levels were associated with fluctuation (p=0.007 and <0.001 respectively). In a multivariable model only sCr remained significant (p<0.001).
Conclusion
Wide fluctuation in sCr is observed in non-flaring patients with LN. The typically used 115% cutoff is too restrictive, and a 125% cutoff might be more reasonable. The fluctuation tends to occur more in patients with low sCr, where small absolute changes in sCr represent large percentage point changes.
| Group | Patients, n | Samples per patient, Median | Age, mean ±SD (yrs) | % Female | Race White, Black, Asian, Other (%) | ISN class III/IV, III + V/IV+V, V (%) | Baseline creatinine, mean ±SD (mg/dl) | Induction Drug* CYC, MMF, AZA (%) |
| Fluctuators | 84 | 8 | 29.7±9.9 | 94% | 30%, 11%, 25%, 12% | 76%, 11%, 13% | 0.74 ±0.24 | 50%, 47%, 3% |
| Non-fluctuators | 207 | 7 | 33.44±10.5 | 87% | 50%, 10%, 34%, 6% | 80%, 9%, 11% | 0.94 ±0.41 | 59%, 39%, 2% |
*data from MAINTAIN excluded