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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Suspended |
Unique ID issued by UMIN | UMIN000011916 |
Receipt No. | R000013571 |
Scientific Title | Exploratory evaluation of the potential for long-term retention of Gadolinium in the bones of patients who have received Gadolinium based Contrast Agents according to their medical history. |
Date of disclosure of the study information | 2013/10/01 |
Last modified on | 2015/08/04 |
Basic information | |||||
Public title | Exploratory evaluation of the potential for long-term retention of Gadolinium in the bones of patients who have received Gadolinium based Contrast Agents according to their medical history. | ||||
Acronym | Long-Term Retention of Gadolinium in Bone | ||||
Scientific Title | Exploratory evaluation of the potential for long-term retention of Gadolinium in the bones of patients who have received Gadolinium based Contrast Agents according to their medical history. | ||||
Scientific Title:Acronym | Long-Term Retention of Gadolinium in Bone | ||||
Region |
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Condition | ||
Condition | - MRI with Gadolinium Contrast Agent received (independent of indication)
- Hip or knee surgery planned |
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Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Primary objective:
To prospectively explore the potential for long-term retention of Gd in the bones of patients who have received a single dose of GdCA or multiple doses of the same GdCA, with moderate or severe renal impairment or stable renal function (estimated glomerular filtration rate > 60 ml/min/1.73 m2) at the time of GdCA injection. Secondary objectives: - To evaluate skin samples for concentration of Gd - To evaluate bone and skin samples for concentrations of calcium, phosphorus, sodium, iron, zinc and potassium - To evaluate skin samples for any dermatopathological changes that may be associated with Nephrogenic Sys¬temic Fibrosis (NSF) - To describe potential co-factors for NSF, susceptibility fac¬tors and drug treatments with potential impact on bone metabolism |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Primary evaluation variables:
- Concentration of total Gd in trabecular bone (determined by ICP-MS). - Concentration of total Gd in cortical bone (determined by ICP-MS). |
Key secondary outcomes | Secondary evaluation variables:
- Concentration of total Gd in skin tissue samples (determined by ICP-MS), collected at the time of hip or knee replacement surgery, from a biopsy from the edge of the sur¬gical wound. - Concentrations of calcium, phosphorus, sodium, iron, zinc and potassium in bone (both trabecular and cortical) and skin tissue samples (determined by ICP-MS or al-ternatively ICP-AES if the feasibility evaluation of ICP-MS does not show reliable re¬sults). - Histopathological evaluation of skin samples with regard to the possibility of findings associated with NSF (determined by an experienced dermatopathologist). - Description of potential co-factors for NSF, susceptibility factors and drug treatments with potential impact on bone metabolism. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -but assessor(s) are blinded |
Control | No treatment |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Diagnosis | |
Type of intervention |
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Interventions/Control_1 | Skin Sample collection | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.Patient (Pt.) must be at least 18 years of age
2.Pt. scheduled for hip or knee replacement 3.Pt. is scheduled to have sufficient bone removed during the hip or knee surgical replacement procedure and sufficient non-scarred skin tissue from the edge of the surgical incision to permit sample collection, in the investigator's medical opinion 4.Pt. agreed to have bone and skin samples collected at the time of the surgical procedure(s) 5.Pt.'s surgical procedure and subsequent remission will not be altered by studyspecific skin biopsies, in the investigator's medical opinion 6.Pt. is fully informed about the study and has signed the informed consent form Patients having received GdCA 7.Pt. belongs to one of the following subgroups with respect to the no. of GdCA doses received and the status of their renal function a)Pt. has stable severe renal impairment* and has received one GdCA injection at the standard dose b)Pt. has stable severe renal impairment* and has received more than one injection of the same GdCA c)Pt. has stable moderate renal impairment2* and has received one GdCA injection at the standard dose d)Pt. has stable moderate renal impairment2* and has received more than one injection of the same GdCA e)Pt. has stable renal function3* and has received one GdCA injection at the standard dose f)Pt. has stable renal function3* and has received more than one injection of the same GdCA 8.A minimum of 3 months have elapsed between GdCA dose and scheduled hip or knee replacement 9.Pt. GdCA history, including dose(s), date(s), and product(s) administered is complete and accurate GdCA naive patients (control group) 10.Pt. has never received GdCA before hip / knee replacement 11.Pt. belongs to one of the following renal function categories g)Pt. has stable severe renal impairment* h)Pt. has stable moderate renal impairment2* i)Pt. has stable renal function3* *:eGFR<30 2*:eGFR within the range 30 to 60 3*:eGFR>60 (eGFR units:ml/min/1.73m2) |
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Key exclusion criteria | No patient may enter the study if any of the following exclusion criteria are fulfilled:
1. Patient has received different GdCAs. 2. Patient has received intra-articular GdCA or per any other non-i.v. route. 3. Patient has received or is scheduled to receive GdCA within 3 months prior to the date of hip or knee replacement surgery and study sample collection procedures. 4. Patient has received any investigational product or has participated in any other clinical trial within 30 days prior to enrolling in this study. 5. Patient suspected of, or diagnosed with, tumour in knee / hip bone, metastatic bone and bone marrow disease in knee / hip. Note: Patients shall not be excluded for other bone diseases with the exception of those with bone cancer as specified in exclusion criterion 5. 6. Patient has diagnosed or suspected NSF at time of enrolment. Note: Patients shall not be excluded for diagnosis of NSF subsequent to enrolment. 7. Patient presents with scarring in the region(s) of the scheduled surgical procedure(s) or of the skin sampling location, to the extent that collection of an unscarred skin sample is not feasible. 8. Patient has a close affiliation with the investigational site; e.g., a relative of the investigator, dependent person (e.g., employee or student of the investigational site). |
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Target sample size | 350 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | University Clinic Magdeburg A. ö. R. | ||||||
Division name | Orthopedics University Clinic | ||||||
Zip code | |||||||
Address | Leipziger Str. 44, 39120 Magdeburg, Germany | ||||||
TEL | +49(0)391-67-14000 | ||||||
christoph.lohmann@med.ovgu. |
Public contact | |||||||
Name of contact person |
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Organization | EPS Associates Co., Ltd. | ||||||
Division name | Clinical Development Dept. 1 Pharmaceutical Development Project Division | ||||||
Zip code | |||||||
Address | 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo, 162-0822, Japan | ||||||
TEL | 03-3868-5268 | ||||||
Homepage URL | |||||||
m.fujino.yi@eps-associates.com |
Sponsor | |
Institute | Ecron Acunova GmbH |
Institute | |
Department |
Funding Source | |
Organization | Bayer Pharma AG,
Covidien Pharmaceuticals AG, GE Healthcare AS, Guerbet SA |
Organization | |
Division | |
Category of Funding Organization | Outside Japan |
Nationality of Funding Organization | Germany, Switzerland, UK, France |
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Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | NCT01853163 |
Org. issuing International ID_1 | ClinicalTrials.gov |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Date of disclosure of the study information |
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URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Suspended | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013571 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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