NCT04680780: Keto-ADPKD

Ketogenic Dietary Interventions in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Completed NA Last updated 24 August 2022

What this trial tests

NA trial testing Ketogenic diet in ADPKD in 63 participants. Completed in 12 August 2022.

Timeline

10 January 2021

Primary endpoint
12 August 2022

12 August 2022

Quick facts

Lead sponsor	University of Cologne
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	63
Start date	10 January 2021
Primary completion	12 August 2022
Estimated completion	12 August 2022
Sites	1 location across Germany

Drugs / interventions tested

• Ketogenic diet — full drug profile →
• 3-days water-fasting
• Control

Conditions studied

• ADPKD — all drugs for ADPKD →

Sponsor

University of Cologne

Who can join

Adults 18 to 60, any sex, with ADPKD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A mild reduction in food intake significantly inhibits renal cyst growth in mouse models of ADPKD. The underlying mechanism was unknown at the time. Recently published data show that the beneficial effect is not due to caloric restriction per se but due to the induction of the state of ketosis. Dietary interventions leading to ketosis profoundly inhibited renal cyst growth in rodent models of PKD. In addition, acute fasting led to rapid regression of renal cystic burden in mouse, rat and feline models of PKD. Due to these compelling effects in a multitude of PKD animal models, and due to the fact that well-established dietary interventions have a tremendous translational potential, KETO-ADPKD will test such interventions regimens in ADPKD patients.

Two well-established ketogenic dietary regimens will be tested in comparison to a control group to address the following four questions:

1. Feasibility: Are ketogenic dietary interventions acceptable to ADPKD patients in everyday life?
2. Safety: Are there adverse events of ketogenic dietary interventions in ADPKD patients?
3. Efficacy: Do the dietary interventions reach the metabolic endpoints? Do they have a short-term impact on kidney volume?
4. Which of the two diets is the optimal approach?

These questions will be addressed in an exploratory, randomized, open, single center, three-arm dietary intervention study using the following interventions in 21 ADPKD patients per treatment arm:

A) Ketogenic diet B) 3-day water fasting C) Control: ad libitum food intake (no diet)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Feasibility and impact of ketogenic dietary interventions in polycystic kidney disease: KETO-ADPKD-a randomized controlled trial.
   Cukoski S, Lindemann CH, Arjune S, Todorova P, et al · · 2023 · cited 45× · PMID 37935200 · DOI 10.1016/j.xcrm.2023.101283
2. Autosomal Dominant Polycystic Kidney Disease: From Pathophysiology of Cystogenesis to Advances in the Treatment.
   Reiterová J, Tesař V. · · 2022 · cited 40× · PMID 35328738 · DOI 10.3390/ijms23063317
3. Insights Into the Molecular Mechanisms of Polycystic Kidney Diseases.
   Vasileva VY, Sultanova RF, Sudarikova AV, Ilatovskaya DV. · · 2021 · cited 29× · PMID 34566674 · DOI 10.3389/fphys.2021.693130
4. RESET-PKD: a pilot trial on short-term ketogenic interventions in autosomal dominant polycystic kidney disease.
   Oehm S, Steinke K, Schmidt J, Arjune S, et al · · 2023 · cited 28× · PMID 36423335 · DOI 10.1093/ndt/gfac311
5. Sodium-glucose cotransporter inhibition in polycystic kidney disease: fact or fiction.
   Afsar B, Afsar RE, Demiray A, Altay S, et al · · 2022 · cited 28× · PMID 35756735 · DOI 10.1093/ckj/sfac029
6. Dietary Interventions in Autosomal Dominant Polycystic Kidney Disease.
   Pickel L, Iliuta IA, Scholey J, Pei Y, et al · · 2022 · cited 14× · PMID 34755831 · DOI 10.1093/advances/nmab131
7. Higher beta-hydroxybutyrate ketone levels associated with a slower kidney function decline in ADPKD.
   Knol MGE, Bais T, Geertsema P, Connelly MA, et al · · 2024 · cited 9× · PMID 37974030 · DOI 10.1093/ndt/gfad239
8. Metabolism-based approaches for autosomal dominant polycystic kidney disease.
   Bakaj I, Pocai A. · · 2023 · cited 9× · PMID 36876046 · DOI 10.3389/fmolb.2023.1126055