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NCT02497521: AD(H)PKD
The German ADPKD Tolvaptan Treatment Registry is a Prospective, Observational, Multicentric Study of Patients Suffering From ADPKD That Are Considered for Tolvaptan Treatment.
trial in ADPKD (Autosomal Dominant Polycystic Kidney Disease) in 2,000 participants. Currently enrolling.
1 December 2027
Quick facts
| Lead sponsor | University of Cologne |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 2,000 |
| Start date | 1 November 2015 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 December 2027 |
| Sites | 12 locations across Germany |
Conditions studied
- ADPKD (Autosomal Dominant Polycystic Kidney Disease) — all drugs for ADPKD (Autosomal Dominant Polycystic Kidney Disease) →
Sponsor
University of Cologne
Who can join
18 and older, any sex, with ADPKD (Autosomal Dominant Polycystic Kidney Disease). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Drug dosing and titration as a measure of changes in real-life setting
Time frame: 10 years
Drug dosing and titration as a measure of maximum dose and the final dose and how fast it is achieved -
Urine osmolarity as a measure of appropriate dosing
Time frame: 10 years
Data on urine osmolarity will be collected to measure appropriate dosing to provide the desired protective effect -
Evaluation of rate of drug discontinuation and average Duration of therapy
Time frame: 10 years
Evaluation of rate of drug discontinuation and average Duration of therapy
Sponsor's own description
The German ADPKD Tolvaptan Treatment Registry is a prospective, observational, multicentric study of patients suffering from ADPKD that are considered for tolvaptan treatment. All ADPKD patients that are evaluated for treatment indication, or that are planned to be treated with tolvaptan, or that are already treated with tolvaptan are eligible. This registry is designed to provide "real-world" data on treatment management of patients with ADPKD.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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 -
Management of autosomal-dominant polycystic kidney disease-state-of-the-art.
Müller RU, Benzing T. · · 2018 · cited 29× · PMID 30581561 · DOI 10.1093/ckj/sfy103 -
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 -
Cardiac Manifestations in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD): A Single-Center Study.
Arjune S, Grundmann F, Todorova P, Todorova P, et al · · 2023 · cited 13× · PMID 36821607 · DOI 10.34067/kid.0002942022 -
Matrix Metalloproteinase-7 in Urinary Extracellular Vesicles Identifies Rapid Disease Progression in Autosomal Dominant Polycystic Kidney Disease.
van Heugten MH, Blijdorp CJ, Arjune S, van Willigenburg H, et al · · 2024 · cited 12× · PMID 38073039 · DOI 10.1681/asn.0000000000000277 -
Automated Kidney and Liver Segmentation in MR Images in Patients with Autosomal Dominant Polycystic Kidney Disease: A Multicenter Study.
Woznicki P, Siedek F, van Gastel MDA, Dos Santos DP, et al · · 2022 · cited 11× · PMID 36591351 · DOI 10.34067/kid.0003192022 -
DKK3 as a potential novel biomarker in patients with autosomal polycystic kidney disease.
Arjune S, Späth MR, Oehm S, Todorova P, et al · · 2024 · cited 8× · PMID 38186869 · DOI 10.1093/ckj/sfad262 -
Inflammatory Cytokine Levels in Patients with Autosomal Dominant Polycystic Kidney Disease.
Arjune S, Lettenmeier K, Todorova P, Todorova P, et al · · 2024 · cited 7× · PMID 39046800 · DOI 10.34067/kid.0000000000000525
Verify or expand the search:
- PubMed search for NCT02497521
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Currently open trials in the same condition.
- NCT06800651 — Trial of JMKX003142 in Participants With Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) · Phase 2 · recruiting
Other University of Cologne trials
Trials by the same sponsor.
- NCT07280585 — STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease · Phase 3 · recruiting
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- NCT05969431 — Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study · recruiting
- NCT05876221 — Platelet Response to Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura · completed
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 NCT02497521 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Cologne
- Last refreshed: 29 April 2026
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/NCT02497521.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing