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NCT00828347
A Study of Maintenance Therapy After Intravenous Maxacalcitol for Secondary Hyperparathyroidism
NA trial testing 1.0 μg/day Alfacalcidol in Secondary Hyperparathyroidism in 35 participants. Completed in 1 July 2009.
1 July 2009
Quick facts
| Lead sponsor | Kumamoto University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 1 January 2008 |
| Primary completion | 1 July 2009 |
| Estimated completion | 1 July 2009 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- 1.0 μg/day Alfacalcidol — full drug profile →
- 0.25 μg/day Alfacalcidol — full drug profile →
Conditions studied
- Secondary Hyperparathyroidism — all drugs for Secondary Hyperparathyroidism →
Sponsor
Kumamoto University
Who can join
18 and older, any sex, with Secondary Hyperparathyroidism. 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.
-
Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level
Time frame: Participants were followed for 24 weeks
Sponsor's own description
There are still no established protocols for maintenance therapy with intravenous or oral vitamin D preparations after the iPTH target has been achieved. Therefore, the present study compared the efficacy of two maintenance therapy protocols, i.e., oral administration of alfacalcidol (an oral vitamin D preparation) at a dose of 1.0 ug/day (higher-dose group) or at a dose of 0.25 ug/day (lower-dose group), in patients with secondary hyperparathyroidism who responded to initial maxacalcitol therapy, resulting in the control of iPTH to \< 150 pg/mL.
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 NCT00828347
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Secondary Hyperparathyroidism
Currently open trials in the same condition.
- NCT06130683 — Single-Cell Sequence Technology Used to Reveal Heterogeneity of Secondary Hyperparathyroidism · active not recruiting
- NCT05880914 — Precision Medicine Approaches to Renal Osteodystrophy · recruiting
- NCT03969329 — A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis · Phase 3 · recruiting
- NCT03633708 — A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemo · Phase 3 · recruiting
Other Kumamoto University trials
Trials by the same sponsor.
- NCT03248232 — Assessments of Thrombus Formation in TAVI · completed
- NCT02528006 — Treatment for Adductor Spasmodic Dysphonia by Type 2 Thyroplasty Using Titanium Bridges · Phase 2, PHASE3 · 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 NCT00828347 (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 Kumamoto University
- Last refreshed: 16 December 2015
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/NCT00828347.
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