UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011916
Receipt number 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 17:00:16

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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

Japan Asia(except Japan) North America
Europe


Condition

Condition

- MRI with Gadolinium Contrast Agent received (independent of indication)
- Hip or knee surgery planned

Classification by specialty

Not applicable

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

Maneuver

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

18 years-old <=

Age-upper limit


Not applicable

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)

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).

Target sample size

350


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Christoph Lohmann, Prof., MD

Organization

University Clinic Magdeburg A. &ouml;. R.

Division name

Orthopedics University Clinic

Zip code


Address

Leipziger Str. 44, 39120 Magdeburg, Germany

TEL

+49(0)391-67-14000

Email

christoph.lohmann@med.ovgu.


Public contact

Name of contact person

1st name
Middle name
Last name Masami Fujino

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


Email

m.fujino.yi@eps-associates.com


Sponsor or person

Institute

Ecron Acunova GmbH

Institute

Department

Personal name



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


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Suspended

Date of protocol fixation

2012 Year 12 Month 19 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 11 Day

Last follow-up date

2014 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 30 Day

Last modified on

2015 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013571


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name