Rituximab vs. Cyclophosphamide in the Treatment of Membranous Nephropathy: The RI-CYCLO Trial
Bibliographic record
Abstract
Background: Guidelines for membranous nephropathy (MN) management recommend cyclical corticosteroid-cyclophosphamide regimen (CYC) in patients with heavy proteinuria. Rituximab (RTX) may be a viable alternative, but head-to-head comparison is lacking. Methods: Aim of this pilot RCT was to estimate the effects of RTX vs CYC regimen in MN, while assessing the feasibility of a larger trial. After a run-in of at least 3 months, patients with nephrotic syndrome were randomized to receive RTX (1g two weeks apart) or CYC. Complete remission (CR) was defined as proteinuria ≤0.3 g/day, partial remission (PR) as a reduction of proteinuria >50% and an absolute value of 0.3-3.5 g/day. Primary outcome was CR at 12 months; secondary outcomes included CR+PR at 12 and 24 months. Results: 116 pts were screened, 74 randomized. Baseline median serum albumin was 2 g/dL and proteinuria 6 g/day in both arms. At 12 months, 6/37 pts (16%) in the RTX arm and 12/37 (32%) in the CYC arm had CR (OR according to “intention to treat_ ITT” analysis 0.4, 95% CI, 0.13-1.23, OR “according to per protocol_PP“0.28, 95% CI, 0.08-0.95), 23/37 (62%) in the RTX arm and 27/37 (73%) in the cyclical regimen arm had a CR+PR (OR ITT analysis 0.61, 95% CI 0.23-1.63, OR PP 1.11, 95% CI 0.42-2.98). Probabilities of CR and CR+PR at 24 months were 0.42 (CI 0.26-0.62) and 0.83 (CI 0.65-0.95) in the RTX arm and 0.43 (0.28-0.61) and 0.82 (0.68-0.93) in the CYC arm. Serious adverse events occurred in 7 and 5 pts, in the RTX and CYC arm, respectively. Conclusions: Although the probability of CR was lower in the RTX arm at 12 months, the probability of CR at 24 months and of CR+PR at 12 and 24 months was similar in the two groups. No difference in side effects was found. While the efficacy of RTX and CYC in MN appears to be similar, a larger trial adequately powered would be difficult to perform.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".