Other Impaired Renal Function DisorderNCT01945125
Effects of THW and rhTSH in Glomerular Filtration Rate During RIT
A study testing rhTSH Group in people with Other Impaired Renal Function Disorder, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
To observe the influence of thyroid hormone withdrawal and of recombinant human TSH during radioiodine therapy in renal function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Other Impaired Renal Function Disorder
- What is being tested?
- rhTSH Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal Renal Function
Who cannot join
- Abnormal Renal Function
- Renal metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Thyroid Hormone Withdrawal and Recombinant Human Thyroid Stimulating Hormone in Glomerular Filtration Rate During Radioiodine Therapy
To observe the influence of thyroid hormone withdrawal and of recombinant human TSH during radioiodine therapy in renal function.
Read the detailed description
Radioiodine therapy in thyroid carcinoma is a procedure performed for over six decades, and there is a vast literature in respect of its value in the complementary treatment of this neoplasia. This procedure also promotes a reliable follow-up based on sequential thyroglobulin dosages and makes possible to reduce the disease recurrence rate. One of the main aspects of the patients preparation before receiving the radioiodine consists in promoting stimulation for an effective uptake of the radioiodine, obtained either by endogenously TSH level elevation after post-surgical thyroid hormone withdrawal, or exogenously after use of recombinant human TSH. This last alternative does not demand suspension of thyroid hormone reposition after total thyroidectomy. Although not fully comprehended, it is known that hypothyroidism results in renal function hazard, which is reverted after hormonal reposition. It is also known that renal function modifies the radioiodine residence time and that the longer this time, the greater the patient's radiation exposure will be, and consequently with undesired irradiation of healthy tissues and organs. So theoretically stimulating the patient with recombinant human TSH could avoid the transient deficient renal function, promoting a lower radioiodine residence time and consequently lowering radiation exposure in this therapy.
This project aims to evaluate the effects of the different stimulation, endogenous and exogenous, over renal function by glomerular filtration rate determined by 51Cr-EDTA. This will be a controlled and randomized study in which 44 patients that has clinical indication of remnant ablative radioiodine treatment will be prepared by either one of the TSH stimulation procedures. Additionally radiation dosimetry calculus will be done to analyze the levels of the patient's radiation exposure associated with each of the uptake stimulation procedures for radioiodine therapy.
- Conditions
- Other Impaired Renal Function Disorder
- Being tested
- rhTSH Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTSH GroupOther
Patients receiving rhTSH for RIT stimulation
| Study group | Role | What they receive |
|---|---|---|
| THW Group | No intervention | Patients under THW stimulation for RIT |
| rhTSH Group | Other | Patients under rhTSH stimulation for RIT Receives: Other: rhTSH Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of differences in glomerular filtration rate with THW or rhTSH in radioiodine therapy
Measured: participants will be followed during radioiodine treatment, from the decision of treatment to the post treatment whole body scan, an expected average of 2 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startOct 2011
- Primary completionJan 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other Impaired Renal Function DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George B Coura Filho, MD, Principal investigator, ICESP-FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945125
- Sponsor's protocol ID
- NP97/10
- Status last verified
- Nov 2013
- First submitted
- 9 Sep 2013
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Coura-Filho GB, Willegaignon J, Buchpiguel CA, Sapienza MT. Effects of Thyroid Hormone Withdrawal and Recombinant Human Thyrotropin on Glomerular Filtration Rate During Radioiodine Therapy for Well-Differentiated Thyroid Cancer. Thyroid. 2015 Dec;25(12):1291-6. doi: 10.1089/thy.2015.0173. Epub 2015 Nov 5.
PubMed 26446582
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thyroid Hormone Withdrawal and Recombinant Human Thyroid Stimulating Hormone in Glomerular Filtration Rate During Radioiodine Therapy
- ClinicalTrials.gov ID
- NCT01945125
- Acronym / sponsor ID
- NP97/10
- Conditions
- Other Impaired Renal Function Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To observe the influence of thyroid hormone withdrawal and of recombinant human TSH during radioiodine therapy in renal function.
Detailed description
Radioiodine therapy in thyroid carcinoma is a procedure performed for over six decades, and there is a vast literature in respect of its value in the complementary treatment of this neoplasia. This procedure also promotes a reliable follow-up based on sequential thyroglobulin dosages and makes possible to reduce the disease recurrence rate. One of the main aspects of the patients preparation before receiving the radioiodine consists in promoting stimulation for an effective uptake of the radioiodine, obtained either by endogenously TSH level elevation after post-surgical thyroid hormone withdrawal, or exogenously after use of recombinant human TSH. This last alternative does not demand suspension of thyroid hormone reposition after total thyroidectomy. Although not fully comprehended, it is known that hypothyroidism results in renal function hazard, which is reverted after hormonal reposition. It is also known that renal function modifies the radioiodine residence time and that the longer this time, the greater the patient's radiation exposure will be, and consequently with undesired irradiation of healthy tissues and organs. So theoretically stimulating the patient with recombinant human TSH could avoid the transient deficient renal function, promoting a lower radioiodine residence time and consequently lowering radiation exposure in this therapy.
This project aims to evaluate the effects of the different stimulation, endogenous and exogenous, over renal function by glomerular filtration rate determined by 51Cr-EDTA. This will be a controlled and randomized study in which 44 patients that has clinical indication of remnant ablative radioiodine treatment will be prepared by either one of the TSH stimulation procedures. Additionally radiation dosimetry calculus will be done to analyze the levels of the patient's radiation exposure associated with each of the uptake stimulation procedures for radioiodine therapy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THW Group | No intervention | –Patients under THW stimulation for RIT |
| rhTSH Group | Other | Other: rhTSH GroupPatients under rhTSH stimulation for RIT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Normal Renal Function
Key exclusion criteria (2 listed)
- Abnormal Renal Function
- Renal metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhTSH GroupPatients receiving rhTSH for RIT stimulation | Other | rhTSH Group |
Primary outcome
Observation of differences in glomerular filtration rate with THW or rhTSH in radioiodine therapy
Time frame: participants will be followed during radioiodine treatment, from the decision of treatment to the post treatment whole body scan, an expected average of 2 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
- Derived from this study: PubMed 26446582Coura-Filho GB, Willegaignon J, Buchpiguel CA, Sapienza MT. Effects of Thyroid Hormone Withdrawal and Recombinant Human Thyrotropin on Glomerular Filtration Rate During Radioiodine Therapy for Well-Differentiated Thyroid Cancer. Thyroid. 2015 Dec;25(12):1291-6. doi: 10.1089/thy.2015.0173. Epub 2015 Nov 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George B Coura Filho, MD principal investigator
ICESP-FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rhTSH Group in people with Other Impaired Renal Function Disorder, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observation of differences in glomerular filtration rate with THW or rhTSH in radioiodine therapy (time frame: participants will be followed during radioiodine treatment, from the decision of treatment to the post treatment whole body scan, an expected average of 2 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01945125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.