Evidence map›Paper›PMID 41736773›Full record

ReviewKidney international reports2026

Evolution of Clinical Trial Design in ADPKD.

John R Roth, Neera K Dahl, Pranav S Garimella

Abstract readReview
In one paragraph

Review in Kidney international reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

John R RothDepartment of Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Neera K DahlDivision of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota, USA.
Pranav S GarimellaDivision of Nephrology and Hypertension, University of California, San Diego, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is characterized by continuous growth in the size and number of kidney cysts during decades of relatively preserved renal function. Because of this slow progression, traditional clinical trial design, focused on kidney functional outcomes such as change in estimated glomerular filtration rate (eGFR) or time to kidney failure, requires significant investment of time and resources. This review examines the evolution of trial design to overcome these barriers, highlighting the pivotal shift to using total kidney volume (TKV) as a reasonably likely surrogate end point. Foundational studies such as the Consortium for Radiologic Imaging Studies in Polycystic Kidney Disease (CRISP) validated TKV as a prognostic biomarker, enabling a move away from functional end points. Subsequent interventional trials (e.g., HALT-PKD, TEMPO 3:4) further demonstrated the utility of TKV while revealing potential limitations in the relationship between kidney volume and function. Building on these lessons, the field could move to more sophisticated designs to improve efficiency and limit study size. Innovative approaches including adaptive methods, master protocols (i.e., platform and umbrella designs), and target trial emulation may reduce costs, enhance statistical power, and accelerate the development of therapeutic options for ADPKD.

Indexed as

ADPKDbiomarkersclinical trials

Identifiers

PMID41736773
PMCPMC12926507

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.