RANDOMIZED CLINICAL TRIAL COMPARING CYCLOSPORINE MICROEMULSION WITH C2 MONITORING AND TACROLIMUS IN DE NOVO KIDNEY TRANSPLANTATION
Bibliographic record
Abstract
A74 Aims: Previous studies comparing cyclosporine (Neoral, CsA) and tacrolimus (TAC) were based on trough monitoring. The benefit of C2 monitoring for CsA has since been recognised. The present study was designed to compare the efficacy and safety of a CsA regimen based on C2 monitoring to a TAC regimen based on trough monitoring in de novo kidney transplantation. Methods: We report the 1 year post transplant results. Total 39 patients were randomized to either CsA or TAC. CsA was administered at an initial dose of 15 mg/kg/day and TAC at 0.1 mg/kg/day. Both arms received mycophenolate mofetil and prednisone. No antibody induction was used. During the first two months daily dose of CsA was adjusted to target C2 levels of 1700-2100 ng/ml, month three 1200-1500 ng/ml, month four to six 1000-1200 ng/ml and after 6 month 600-1000 ng/ml. TAC was adjusted to target trough level of 8-12 ng/ml in the first 3 month and 6-10 ng/ml thereafter. Protocol biopsies were done at month 1, 3 and 6 post transplant. Results: Analysis was based on intention to treat population. Biopsy-proven acute rejection (clinical and subclinical) was found in 8 (44.4%) in the CsA arm (n=18) compared to 7 (41.2%) in the TAC arm (n=17). Clinical rejection was present in only 7 (38.8%) versus 4 (23.5%); (CsA vs. TAC, respectively). The severity of rejection was comparable (BANFF criteria). There was no graft loss in either group. One patient in TAC group died due to Pneumocystis Carnii. Renal function measured as creatinine clearance (Cockcroft-Gault) at 1, 3 and 6 months though higher in TAC group but were not stastistically different. The 1 year creatinine clearence was significantly higher in TAC group (CsA vs. TAC; 56.57 vs. 85.73, p=0.01) The incidence of new-onset of diabetes mellitus (NODM) post transplant was similar (CsA vs.TAC; 1 vs. 2, p=ns) as was the incidence of new onset hyperlipidemia (CsA vs. TAC; 8 vs.7, p=ns). Conclusions: De novo kidney transplant recipients treated with Neoral C2 or TAC both had similar rates of clinical and subclinical acute rejection. The renal function at 1 year was higher in TAC group. The use of tacrolimus was not associated with a higher incidence of NODM, possibly because target ranges of tacrolimus were kept low.
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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 | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.008 | 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".