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NCT03489993: GAP
FGF23 and Angiotensin-(1-7) in Hypophosphatemia (GAP)
trial testing Ang II and Ang-(1-7) in Hypophosphatemia in 8 participants. Completed in 23 December 2020.
23 December 2020
Quick facts
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 8 |
| Start date | 6 December 2018 |
| Primary completion | 23 December 2020 |
| Estimated completion | 23 December 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ang II and Ang-(1-7)
- FGF23 and klotho
Conditions studied
- Hypophosphatemia — all drugs for Hypophosphatemia →
- X-linked Hypophosphatemia — all drugs for X-linked Hypophosphatemia →
- Renin-angiotensin System — all drugs for Renin-angiotensin System →
- Left Ventricular Hypertrophy — all drugs for Left Ventricular Hypertrophy →
Sponsor
Wake Forest University Health Sciences
Who can join
Adults 2 to 24, any sex, with Hypophosphatemia or X-linked Hypophosphatemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hereditary hypophosphatemia encompasses rare genetic conditions characterized by renal phosphate wasting. Increased circulating levels of fibroblast growth factor 23 (FGF23), a key regulator of phosphorus metabolism, are critical to the pathophysiology of these diseases, most notably in X-linked hypophosphatemia (XLH). Increased FGF23 induces hypertrophy and scarring in the heart in part via stimulating the traditional renin-angiotensin system (RAS) pathway, angiotensin-converting enzyme (ACE)/angiotensin (Ang ll), particularly in patients with chronic kidney disease, but the effect of FGF23 on the heart in patients with FGF23-related hypophosphatemic diseases is unknown. In addition, the relationship between FGF23 and the angiotensin-converting enzyme 2 (ACE2)/angiotensin-(1-7) (Ang-(1-7) pathway of the RAS is unknown. The objective of this study is to describe the relationship between FGF23, which causes low phosphorus levels, and components of the RAS in the blood and urine to help the investigators understand why the disease occurs and how to better treat it. Subjects will be identified by querying the Electronic Medical Record according to medical diagnosis. Thirty subjects, 2-24 years of age, will be recruited from the tertiary care Pediatric Endocrinology and Pediatric Nephrology clinics at Brenner Children's Hospital. Inclusion criteria include a confirmed diagnosis of hereditary FGF23-related hypophosphatemia. Clinical data will be obtained from the Electronic Medical Record. Each subject will undergo study assessments at baseline, 6 months and 1 year that include blood work, an echocardiogram, and blood pressure measurements. The primary hypothesis is that subjects with higher Ang-(1-7) levels have lower rates of cardiac hypertrophy and thus are protected against high FGF23 levels. The secondary hypothesis is that subjects with higher Ang-(1-7) levels have lower systolic blood pressure.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03489993
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Wake Forest University Health Sciences trials
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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 NCT03489993 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
- Last refreshed: 5 August 2022
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/NCT03489993.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing