NCT04695860 (BurGER) is a Phase 3 clinical trial of Burosumab in X-linked Hypophosphatemia, sponsored by Wuerzburg University Hospital.

Who is sponsoring NCT04695860?

NCT04695860 is sponsored by Wuerzburg University Hospital.

What drugs are being tested in NCT04695860?

Interventions in NCT04695860: Burosumab.

What condition does NCT04695860 study?

NCT04695860 studies X-linked Hypophosphatemia.

Is NCT04695860 still recruiting?

NCT04695860 is currently completed. Last updated 3 May 2023.

Last reviewed 2023-05-03 · How we verify

NCT04695860: BurGER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Anti-FGF23 (Burosumab) in Adult Patients With XLH

Completed Phase 3 Last updated 3 May 2023

What this trial tests

Phase 3 trial testing Burosumab in X-linked Hypophosphatemia in 36 participants. Completed in 17 March 2023.

Timeline

7 January 2021

Primary endpoint
17 March 2023

17 March 2023

Quick facts

Lead sponsor	Wuerzburg University Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	7 January 2021
Primary completion	17 March 2023
Estimated completion	17 March 2023
Sites	1 location across Germany

Drugs / interventions tested

Burosumab (BUROSUMAB) — full drug profile →

Conditions studied

X-linked Hypophosphatemia — all drugs for X-linked Hypophosphatemia →

Sponsor

Wuerzburg University Hospital

Who can join

18 and older, any sex, with X-linked Hypophosphatemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

X-linked hypophosphatemia (XLH) rare genetic disorder due by inactivating mutations in the PHEX gene leading to increased levels in FGF-23. Elevated FGF-23 reduces renal phosphate reabsorbtion and and limits 1-alpha hydroxylase driven Vitamin D activation, eventually leading to phosphate wasting, defective bone mineralization and additional health issues. Burosumab is a recombinant fully human IgG1 monoclonal antibody developed to treat XLH by binding FGF23, thereby restoring normal phosphate homeostasis. BUR03 is a Phase 3b open-label, single-arm, single-center study to confirm the efficacy and safety of Burosumab treatment in adult (age ≥18 years) XLH patients without upper age limit and irrespective of baseline pain level and to further evaluate the efficacy in this cohort and the assocaited effect of treatment on physical functioning, mobility and activity. The study aims at enrolling and treating 34 subjects with a confirmed diagnosis of XLH with q4w s.c. injection of Burosumab 1mg/kg body weight over 48 weeks. Primary objective is to attiain normal serum phosphorus levels, secondary objectives include key parameters of physical function and activity, mobility and mineral homeostasis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The Saga of Endocrine FGFs.
Phan P, Saikia BB, Sonnaila S, Agrawal S, et al · · 2021 · cited 48× · PMID 34572066 · DOI 10.3390/cells10092418

Verify or expand the search:

Other trials of Burosumab

Trials testing the same drug.

NCT05509595 — Burosumab for Fibroblast Growth Factor-23 Mediated Hypophosphatemia in Fibrous Dysplasia · Phase 2 · completed
NCT05181839 — A Study to Describe the Lived Experience of XLH for Adolescents at End of Skeletal Growth · completed
NCT04188964 — Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Patients Less Than 1 Year of Age · Phase 1, PHASE2 · completed
NCT03920072 — Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH · Phase 3 · completed
NCT03581591 — Open Label Trial Assessing Safety and Efficacy of Burosumab (KRN23), in a Patient With ENS and Hypophosphatemic Rickets · Phase 3 · completed

Other recruiting trials for X-linked Hypophosphatemia

Currently open trials in the same condition.

NCT06525636 — A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia · Phase 1, PHASE2 · recruiting

Other Wuerzburg University Hospital trials

Trials by the same sponsor.

NCT07084480 — Giant Cell Arteritis - Ways to Precision Medicine · recruiting
NCT07040189 — Gustabor Phase 1 - AI-based Creation of a Nutritional Plan to Compensate for Chemotherapy-induced Taste Disorders · NA · not yet recruiting
NCT06550908 — Training Physicians to Differentiate the Paris Classification Using Artificial Colon Polyp Images · NA · recruiting
NCT07108569 — Ability of Physicians to Distinguish Real From Artificial Colon Polyp Images · NA · completed
NCT06553326 — EndoStyle: Artificial Intelligence Image Transformation Tool for Colonoscopy · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04695860 (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 Wuerzburg University Hospital
Last refreshed: 3 May 2023

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/NCT04695860.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing