clinical trial simulations to optimise analysis strategies for multiple endpoints highlight the trade-off between statistical efficiency and interpretability
#ttvguide
www.nature.com/articles/s41...
It seems to be a recurring problem, though. As you can see from the link above, Science's team found that several of these clinical centers have previously fouled up trial data for other companies and other drugs, and that alone should make any responsible CRO avoid them like radioactive waste zones. But the problems are even deeper. It appears that many of these Miami-area centers are cheerfully enrolling "professional patients" who are signing up for as many trials as possible to collect the payments and benefits, and who are likely as not throwing the pills themselves away. By this point in the article, my head was in my hands, and I'm sure that's a common reaction. This sort of idiotic fraud is the exact opposite of medical research.
Remember the TOPCAT story of what happened in Russia and Georgia?
This is worse: www.science.org/content/blog...
And in South Florida.
From @dereklowe.bsky.social
A Man with Asymptomatic Hypertension Sarah Gorey, M.B. You are the intern on call for the night shift. You are paged to come to the surgical ward to assess a patient. A 63-year-old man with uncomplicated diverticulitis was admitted earlier in the day for antimicrobial and conservative treatment. He rarely visits his family doctor, is not aware of having high blood pressure, and does not take regular medications. You have been called because on a routine check of vital signs, the patient’s blood pressure was 185/115 mm Hg. All other vital signs were within normal limits. The patient has no symptoms; he has no headache, dyspnea, or chest or abdominal pain. He reports feeling slightly stressed at being admitted to the hospital today, which he was not anticipating, but had been sleeping comfortably before the nurse checked his vital signs. On examination, he appears to be comfortable, and there is no clinical evidence of withdrawal from alcohol or other substances. His abdomen is soft and nontender, and on auscultation, no bruits are heard over the aorta or renal arteries. His pulses are 2+ and symmetric in all anatomical distributions. You note that his blood pressure was also high (166/97 mm Hg) at admission 4 hours earlier and had not been measured again until now. Routine laboratory test results from blood samples obtained at the time of admission show increased levels of leukocytes and inflammatory markers but normal kidney and liver profiles. The nurse manager confirms that the blood-pressure monitors on this ward have been calibrated recently. A repeat blood-pressure measurement obtained after the patient has rested quietly for 10 minutes is still elevated, at 182/103 mm Hg. You must decide whether the patient’s blood pressure should be monitored over time on an outpatient basis (a “watchful waiting” approach) or whether he should begin receiving antihypertensive medications during this hospitalization.
Should we be treating inpatient hypertension?
Interesting case with two discussants (Michael Rothberg vs Tara Chang)
www.nejm.org/doi/full/10....
I have to confess despite being a nihilist for treating inpatient BP I am tempted to do something in this setting.
our dietitian mentioned that the oil of the control group is proinflammatory which might explain the difference
what do you and @freelyfiltered.bsky.social think? 🙏
so whats the fup study?
-> repeat in >70a old immunosuppressed patients?
total n=1000
no screening in Austria 🇦🇹 😥
Torque Teno Virus 🦠
ads to SOC to predict BK viraemia
🦠 can be 🦸♀️ #ttvguide
www.sciencedirect.com/science/arti...
thanks 🙏 BTS for the invitation!
what a warm welcome to london 🇬🇧
I guess DSA, GEP, ddcfDNA and TTV will nicely come together as comprehensive immune monitoring post SOT
bts.org.uk/bts-autumn-s...
#TTVguide
Immune Monitoring Goes Viral 🦠 Torque Teno Virus
for Immunologic Risk Stratification After Kidney Transplantation
⏩️ new review in TI 🔥
doi.org/10.3389/ti.2...
#ttvguide
The second sibeprenlimab paper in @nejm.org
(At least we gave it an oral at #KidneyWk unlike the poster for the phase 2 data in 2023!)
www.nejm.org/doi/full/10....
And another ns-MRA
Balcinrenone added to Dapa in proteinuric CKD
#KidneyWK
@thelancet.com
www.thelancet.com/journals/lan...
American Society of Nephrology Kidney Week 2025 Original Article | Nov. 6, 2025 | NEJM.org A Phase 3 Trial of Atacicept in Patients with IgA Nephropathy Figure 2A. Change from Baseline in 24-Hr Urinary Protein-to-Creatinine Ratio through Week 36. The NEJM identity sits at the bottom.
ORIGIN phase 3 trial: In an interim analysis of a clinical trial, atacicept, a fusion protein that binds and inhibits two cytokines thought to be central to the pathophysiology of IgA nephropathy, significantly reduced proteinuria. nej.md/3JEq8QL
@asnkidney.bsky.social | #KidneyWk
Figure 2. Change in bodyweight (A) Mean percent change in bodyweight from baseline to week 48, shown as observed means and bars indicating SEs. The model-based estimates of the mean percent change in bodyweight and differences among treatment groups at week 48 with the corresponding p values (efficacy estimand only) and 95% CIs are shown in (B) (efficacy estimand) and (D) (treatment-regimen estimand); bars indicate SEs. Multiplicity adjustment was not performed, and p values should be interpreted as exploratory. (C) shows the percentage of participants with bodyweight reductions of at least 5%, 10%, 15%, 20%, 25%, and 30% from baseline to week 48. The percentage of participants is annotated above each bar, calculated with the use of Rubin's rules by combining the percentages of participants who met the thresholds in imputed datasets. *The model-based estimates and 95% CIs from a mixed model repeated measures analysis for the efficacy estimand are shown on the right, denoted by 48.
Eli Lilly continuing to hit it out the park
Selective amylin agonist as an alternative to GLP1RAs? #eloralintide
www.thelancet.com/journals/lan... in @thelancet.com
(Yeah I know it’s #KidneyWk but what do we do till Houston wakes up!)
cc @rnflex.bsky.social
Another simultaneous publication from the afternoon session
Albuminuria as an acceptable surrogate outcome (per our discussion earlier today)
www.nature.com/articles/s41... in @naturemedicine.bsky.social @nature.com sadly paywalled
#KidneyWk
a conservative dialysis strategy in possibly recovering AKI helps people recover faster!
jamanetwork.com/journals/jam...
in @jama.com from #KidneyWk
Like STARRT-AKi et al, at the other end? Small trial - needs replication or this is common sense?
low dose Tac + Everolimus is not superior to Tac + MMF in older transplant recipients
in @asnpublications.bsky.social
another LBCT from #KidneyWk published
journals.lww.com/jasn/fulltex...
😲 too good to be true?
nothing except tx reduces death on hd
and now….
something safe, cheep and with more effect than tx (and more effect than in non hd)
waiting for the @freelyfiltered.bsky.social podcast covering this paper
www.nejm.org/doi/full/10....
Visual abstract Sad story reflecting that most people start with HD and most of them die
Natural history of RRT from the ERA registry
The visual abstract in this case tells a lot
academic.oup.com/ndt/advance-...
@ndt-era.bsky.social #NephSky
>50% hd to death 😥
Should we be screening every young child’s urine (as is done in some countries!)
@rheaultm.bsky.social and Oliver Gross make the case in @kireports.bsky.social
www.kireports.org/article/S246...
Main issue: we have therapeutic options!
#NephSky
can viruses 🦠 be superheroes 🦸♂️ ?
PhD student Felix Herkner just published the statistical analysis plan
of the TTVguideIT trial 💪👏
Torque Teno virus guided immunosuppression #TTVguide
data cleaning until Q1/26
analysis Q2/26
trialsjournal.biomedcentral.com/articles/10....
As expected, Iptacopan phase 3 in IgA nephropathy slows GFR decline
APPLAUSE-IgA
Adding another new medication we won’t be able to access or afford to our IgA armamentarium
#NephSky
www.novartis.com/news/media-r...
Big win for telitacicept in SLE (not lupus nephritis, yet)
www.nejm.org/doi/full/10....
BAFF + APRIL FTW
#nephSky #Lupus
congrats to the poster price 🥳
viruses 🦠 can be superheroes 🦸♀️
Felix Herkner present
the statistical analysis plan
of the TTVguideIT trial
at the Austrian Transplant Congress
Torque Teni Virus guided immunosuppression #TTVguide
ah grad auf pubmed gefunden… und sie plant eine randomisiert kontrollierte studie zum thema apherese… find ich super… genau so eine studie fehlt
und wieso reicht sie nicht einfach einen antrag ein zur finanzierung ihrer wissenschaft bei drittmittelgebern, so wie alle anderen das machen, die auch forschung in der medizin machen und 0 oeffentlich gelder bekommen?
