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Long-Term Retention of Gadolinium in Bone
NA trial testing Gadolinium analysis in bone and tissue samples in Focus: Long-term Retention of Gadolinium-based Contrast Agent in 92 participants. Completed in 17 December 2018.
| Lead sponsor | Navitas Life Sciences GmbH |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 92 |
| Start date | 6 May 2013 |
| Primary completion | 5 December 2018 |
| Estimated completion | 17 December 2018 |
| Sites | 16 locations across Japan, Germany, South Korea, United States, Turkey (Türkiye), Spain |
Navitas Life Sciences GmbH
18 and older, any sex, with Focus: Long-term Retention of Gadolinium-based Contrast Agent. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Concentration of total Gd in trabecular bone determined by ICP-MS
| Group | Value | 95% CI |
|---|---|---|
| GBCA Exposure Group - Normal Renal Function | 0.335 | ± 476.7 |
| GBCA Exposure Group - Impaired Renal Function | 0.783 | ± 413.8 |
| GBCA Naive - Control Group With Normal Renal Function | 0 | ± 0 |
| GBCA Naive - Control Group With Impaired Renal Function | 0 | ± 0 |
Concentration of total Gd in cortical bone determined by ICP-MS
| Group | Value | 95% CI |
|---|---|---|
| GBCA Exposure Group - Normal Renal Function | 0.298 | ± 467.5 |
| GBCA Exposure Group - Impaired Renal Function | 0.680 | ± 410.3 |
| GBCA Naive - Control Group With Normal Renal Function | 0 | ± 0 |
| GBCA Naive - Control Group With Impaired Renal Function | 0 | ± 0 |
Concentration of total Gd in skin tissue samples (determined by ICP-MS (inductively coupled plasma mass spectrometry)), collected at the time of the scheduled orthopaedic surgical procedure, from a biopsy from the edge of the surgical wound or the amputated part. Analysation of a single skin tissue sample; in case of a second surgery a further sample was taken.
| Group | Value | 95% CI |
|---|---|---|
| GBCA Exposure Group - Normal Renal Function | 0 | ± 0 |
| GBCA Exposure Group - Impaired Renal Function | 0 | ± 0 |
| GBCA Naive - Control Group With Normal Renal Function | 0 | ± 0 |
| GBCA Naive - Control Group With Impaired Renal Function. | 0 | ± 0 |
Concentration of calcium in skin tissue samples determined by ICP-MS
| Group | Value | 95% CI |
|---|---|---|
| GBCA Exposure Group - Normal Renal Function | 653.268 | ± 65.9 |
| GBCA Exposure Group - Impaired Renal Function. | 651.478 | ± 55.6 |
| GBCA Naive - Control Group With Normal Renal Function | 474.377 | ± 78.8 |
| GBCA Naive - Control Group With Impaired Renal Function | 790.700 | ± 105.8 |
Concentration of calcium in cortical bone tissue samples determined by ICP-MS
| Group | Value | 95% CI |
|---|---|---|
| GBCA Exposure Group - Normal Renal Function | 96908.336 | ± 31.8 |
| GBCA Exposure Group - Impaired Renal Function. | 92491.896 | ± 34 |
| GBCA Naive - Control Group With Normal Renal Function | 142662.680 | ± 11.8 |
| GBCA Naive - Control Group With Impaired Renal Function | 118447.534 | ± 25.5 |
Concentrations of phosphorus in cortical bone tissue samples determined by ICP-MS
| Group | Value | 95% CI |
|---|---|---|
| GBCA Exposure Group - Normal Renal Function. | 52361.735 | ± 30 |
| GBCA Exposure Group - Impaired Renal Function. | 50247.073 | ± 32.1 |
| GBCA Naive - Control Group With Normal Renal Function | 73151.974 | ± 12.7 |
| GBCA Naive - Control Group With Impaired Renal Function | 62689.679 | ± 21.6 |
Concentrations of sodium in cortical bone tissue samples determined by ICP-MS
| Group | Value | 95% CI |
|---|---|---|
| GBCA Exposure Group - Normal Renal Function. | 5642.001 | ± 22.3 |
| GBCA Exposure Group - Impaired Renal Function | 5768.821 | ± 19.2 |
| GBCA Naive - Control Group With Normal Renal Function | 5437.226 | ± 15.6 |
| GBCA Naive - Control Group With Impaired Renal Function | 5511.498 | ± 28.2 |
Concentrations of zinc in cortical bone tissue samples determined by ICP-MS
| Group | Value | 95% CI |
|---|---|---|
| GBCA Exposure Group - Normal Renal Function | 78.516 | ± 29 |
| GBCA Exposure Group - Impaired Renal Function | 79.900 | ± 24.7 |
| GBCA Naive - Control Group With Normal Renal Function | 92.622 | ± 12.1 |
| GBCA Naive - Control Group With Impaired Renal Function | 89.539 | ± 19.1 |
Concentration of potassium in bone (cortical) tissue samples determined by ICP-MS
| Group | Value | 95% CI |
|---|---|---|
| GBCA Exposure Group - Normal Renal Function | 488.128 | ± 41.5 |
| GBCA Exposure Group - Impaired Renal Function | 543.211 | ± 61.9 |
| GBCA Naive - Control Group With Normal Renal Function | 541.822 | ± 51.1 |
| GBCA Naive - Control Group With Impaired Renal Function | 426.705 | ± 65.4 |
Concentrations of iron in bone (cortical) tissue samples determined by ICP-MS
| Group | Value | 95% CI |
|---|---|---|
| GBCA Exposure Group - Normal Renal Function | 38.807 | ± 71.9 |
| GBCA Exposure Group - Impaired Renal Function | 41.116 | ± 118.9 |
| GBCA Naive - Control Group With Normal Renal Function. | 57.069 | ± 88.5 |
| GBCA Naive - Control Group With Impaired Renal Function | 32.293 | ± 109.8 |
Concentrations of calcium in trabecular bone tissue samples determined by ICP-MS
| Group | Value | 95% CI |
|---|---|---|
| GBCA Exposure Group - Normal Renal Function | 124671.921 | ± 22.2 |
| GBCA Exposure Group - Impaired Renal Function | 116601.987 | ± 24.2 |
| GBCA Naive - Control Group With Normal Renal Function | 145859.369 | ± 20.3 |
| GBCA Naive - Control Group With Impaired Renal Function | 143735.414 | ± 11.5 |
Concentrations of phosphorus in bone (trabecular) tissue samples determined by ICP-MS
| Group | Value | 95% CI |
|---|---|---|
| GBCA Exposure Group - Normal Renal Function. | 65887.298 | ± 17.7 |
| GBCA Exposure Group - Impaired Renal Function | 62333.483 | ± 18.4 |
| GBCA Naive - Control Group With Normal Renal Function | 74988.227 | ± 20.8 |
| GBCA Naive - Control Group With Impaired Renal Function | 74435.230 | ± 11.7 |
Time frame: Any AE occurring while a patient was in the study (from informed consent until follow-up visit 2 (visit 4 in case of second surgery) taking place approximately within 10-14 days post-surgery).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | GBCA Exposure Group | GBCA Naive Control Group |
|---|---|---|---|
| Cardiac Failure Congestive | Cardiac disorders | — | — |
| Overdose | Injury, poisoning and procedural complications | — | — |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Delirium | Psychiatric disorders | — | — |
| Renal Failure | Renal and urinary disorders | — | — |
| Nephrogenic Systemic Fibrosis | Skin and subcutaneous tissue disorders | — | — |
| Reaction | System | GBCA Exposure Group | GBCA Naive Control Group |
|---|---|---|---|
| Gastrointestinal Disorders | Gastrointestinal disorders | — | — |
| Injury, Poisoning And Procedural Complications | Injury, poisoning and procedural complications | — | — |
| Psychiatric Disorders | Psychiatric disorders | — | — |
| Vascular Disorders | Vascular disorders | — | — |
| Musculoskeletal And Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | — | — |
| General Disorders And Administration | General disorders | — | — |
| Infections And Infestations | Infections and infestations | — | — |
| Investigations | Investigations | — | — |
| Skin And Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | — | — |
| Metabolism And Nutrition Disorders | Metabolism and nutrition disorders | — | — |
| Nervous System Disorders | Nervous system disorders | — | — |
| Renal And Urinary Disorders | Renal and urinary disorders | — | — |
| Respiratory, Thoracic And Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | — | — |
| Blood And Lymphatic System Disorders | Blood and lymphatic system disorders | — | — |
| Cardiac disorder | Cardiac disorders | — | — |
Most-reported serious reactions: Cardiac Failure Congestive, Overdose, Acute Respiratory Failure, Pneumonia, Delirium, Renal Failure, Nephrogenic Systemic Fibrosis.
Data from ClinicalTrials.gov NCT01853163 adverse events section.
The main objective was to prospectively explore the potential for long-term retention of Gadolinium (Gd) in bones in patients who have received a single dose of Gadolinium-based contrast agents (GBCA) or multiple doses of the same GBCA, with moderate or severe renal impairment or stable normal renal function (eGFR \> 60 ml/min/1.73 m2) at the time of GBCA injection.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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