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NCT04907799
Daily Caloric Restriction in ADPKD
NA trial testing Daily caloric restriction in Autosomal Dominant Polycystic Kidney in 125 participants. Participants enrolled and being followed up; not accepting new ones.
30 June 2027
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 125 |
| Start date | 3 November 2021 |
| Primary completion | 30 June 2027 |
| Estimated completion | 30 June 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Daily caloric restriction
- Standard advice control
Conditions studied
- Autosomal Dominant Polycystic Kidney — all drugs for Autosomal Dominant Polycystic Kidney →
- Overweight and Obesity — all drugs for Overweight and Obesity →
Sponsor
University of Colorado, Denver
Who can join
Adults 18 to 65, any sex, with Autosomal Dominant Polycystic Kidney or Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical trial will determine whether a daily-caloric restriction-based weight loss intervention can slow kidney growth in adults with autosomal dominant polycystic kidney disease who are overweight or obese. The study will also evaluate changes in abdominal fat by magnetic resonance imaging. Blood and fat samples will provide insight into biological changes that may contribute to any observed benefits of the intervention.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Weight loss and cystic disease progression in autosomal dominant polycystic kidney disease.
Hopp K, Catenacci VA, Dwivedi N, Kline TL, et al · · 2022 · cited 36× · PMID 35059607 · DOI 10.1016/j.isci.2021.103697 -
Polycystic Kidney Disease Diet: What is Known and What is Safe.
Chebib FT, Nowak KL, Chonchol MB, Bing K, et al · · 2024 · cited 24× · PMID 37729939 · DOI 10.2215/cjn.0000000000000326 -
Neuronal cilia in energy homeostasis.
Brewer KM, Brewer KK, Richardson NC, Berbari NF. · · 2022 · cited 22× · PMID 36568981 · DOI 10.3389/fcell.2022.1082141 -
Visceral Adiposity and Progression of ADPKD: A Cohort Study of Patients From the TEMPO 3:4 Trial.
Nowak KL, Moretti F, Bussola N, Steele CN, et al · · 2024 · cited 13× · PMID 38608748 · DOI 10.1053/j.ajkd.2024.02.014 -
Metabolism-based approaches for autosomal dominant polycystic kidney disease.
Bakaj I, Pocai A. · · 2023 · cited 9× · PMID 36876046 · DOI 10.3389/fmolb.2023.1126055 -
Overweight Status, Obesity, and Progression to ESKD in Patients with Autosomal Dominant Polycystic Kidney Disease.
Nowak KL, Copeland TP, Ku E, Sarnak MJ, et al · · 2025 · cited 8× · PMID 39970002 · DOI 10.2215/cjn.0000000640 -
Obesity, Weight Loss, Lifestyle Interventions, and Autosomal Dominant Polycystic Kidney Disease.
Steele C, Nowak K. · · 2022 · cited 6× · PMID 35350649 · DOI 10.3390/kidneydial2010013
Verify or expand the search:
- PubMed search for NCT04907799
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Daily caloric restriction
Trials testing the same drug.
- NCT06496542 — Renal Oxygen Consumption, Insulin Sensitivity, and Daily Caloric Restriction in ADPKD · NA · active not recruiting
Other recruiting trials for Autosomal Dominant Polycystic Kidney
Currently open trials in the same condition.
- NCT06582875 — Glucagon-Like Peptide-1 Receptor Agonist in ADPKD · Phase 2 · recruiting
- NCT06496542 — Renal Oxygen Consumption, Insulin Sensitivity, and Daily Caloric Restriction in ADPKD · NA · active not recruiting
- NCT05478083 — A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease · Phase 2 · recruiting
- NCT06759142 — Analysis of Patients With Autosomal Dominant Polycystic Kidney · recruiting
- NCT03273413 — Statin Therapy in Patients With Early Stage ADPKD · Phase 4 · active not recruiting
Other University of Colorado, Denver trials
Trials by the same sponsor.
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- NCT07021937 — Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity · Phase 3 · not yet recruiting
- NCT07453732 — Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients. · NA · not yet recruiting
- NCT07038278 — 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma · EARLY_PHASE1 · not yet recruiting
- NCT07279558 — Cannabidiol and Alcohol Use Disorder Phenotypes · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04907799 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
- Last refreshed: 12 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04907799.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing