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NCT01464931COMPLETEDanonymous

An Open-label Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg Administered Subcutaneously in Subjects With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis

Sponsor

Source record

Amgen

Phase

Source record

PHASE1

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Denosumab

Indication / condition

AI-normalized

Renal Impairment

Intervention

Source record

Denosumab

Source & freshness

Source record

NCT ID

NCT01464931

Original source

ClinicalTrials.gov

Source last updated

Feb 19, 2016

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT01464931

Title

An Open-label Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg Administered Subcutaneously in Subjects With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis

Sponsor

Amgen

Status

COMPLETED

Phase

PHASE1

Condition raw

Renal Impairment

Condition normalized

Renal Impairment

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

Denosumab

Target normalized

Denosumab

Interventions

Denosumab

Public preview

Source record

The primary objective was to evaluate the incidence of clinically significant hypocalcemia following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic kidney disease (CKD) and CKD on dialysis

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

An Open-label Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg Administered Subcutaneously in Subjects With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT01464931

Status

COMPLETED

Phase

PHASE1

Sponsor

Amgen

Executive brief

Investment-Ready Snapshot

The primary objective was to evaluate the incidence of clinically significant hypocalcemia following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic kidney disease (CKD) and CKD on dialysis

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedFeb 19, 2016
Internal syncJun 11, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT01464931

Indication

Renal Impairment

Modality

monoclonal antibody

Target

Denosumab

Intervention

Denosumab

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.