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Trial registered on ANZCTR


Registration number
ACTRN12612001244897
Ethics application status
Not yet submitted
Date submitted
18/11/2012
Date registered
26/11/2012
Date last updated
26/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy and safety of early double J stent placement in treatment of renal tuberculosis: a novel renal function protective strategy
Scientific title
Outcome of early double J stent placement combine anti-tuberculous drug treatment versus anti-tuberculous drug treatment alone in patients with renal tuberculosis : A prospective randomized controlled trial to find an optimal renal function protective strategy
Secondary ID [1] 281521 0
NIL
Universal Trial Number (UTN)
U1111-1136-5967
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
renal tuberculosis 287747 0
Condition category
Condition code
Renal and Urogenital 288087 288087 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Double J stent placed after starting standard anti-tuberculous drug treatment 2 weeks .
Arm 2: Double J stent placed after starting standard anti-tuberculous drug treatment 6 weeks .
Standard anti-tuberculous drug treatment :
drugs involved:Isoniazide(H), Rifampicin(R),Pyrazinamide(Z) ,Ethambutol(E)
dosage amount and dosage frequency:Isoniazide(H), 300mg or 5mg/kg when weight less than 50kg;Rifampicin(R), 600mg or 10mg/kg when weight less than 50kg;Pyrazinamide(Z), 1500mg when weightless than 50kg;2000mg/d when weight greater than or equal to 50kg but less than75kg;2500mg/d when weight greater than or equal to 75kg;Ethambutol(E),25mg/kg, no more than 2000mg a day . The above data are dose for each time.
2HRZ/4HR means initial 2-month intensive phase of treatment with three or four daily rifampicin, isoniazid, pyrazinamide and ethambutol and followed by a 4-month continuation phase with only rifampicin and isoniazid thrice weekly.
mode of drug administration:oral
Duration:6 months.
Double J stent as an ureteral stent will be placed to ipsilateral ureter in both arms, by means of cystoscope or ureteroscope, the duration of the procedure to place it is about 10 minutes.
Mode of follow-up management:
Arm 1:
Beginning standard anti-tuberculous drug treatment;
2 weeks later: Double J stent placed;
3 months later:Follow-up visit to review;
3 months and 2 weeks later: Replacing double J stent;
6 months later: Ending drug treatment ,removing double J stent,review;
9 months later: Follow-up visit to review;
12 months later: Follow-up visit to review;
18 months later: Follow-up visit to review;
24 months later: The last follow-up visit to review.
Arm 2:
Beginning standard anti-tuberculous drug treatment;
6 weeks later: Double J stent placed;
3 months later:Follow-up visit to review;
4 months and 2 weeks later: Replacing double J stent;
6 months later: Ending drug treatment , removing double J stent, review;
9 months later: Follow-up visit to review;
12 months later: Follow-up visit to review;
18 months later: Follow-up visit to review;
24 months later: The last follow-up visit to review;
Participants will be followed as the above schedule till meeting follow-up endpoint events.
Items for review include computed tomography (CT), plain film of kidney-ureter-bladder and intravenous pyelography(KUB+IVU), ultrasound, radionuclide imaging, urine routine , erythrocyte sedimentation rate(ESR)and acid-fast bacilli in urine.
End point events include: kidney removed; a sever complication occurred due to drugs or surgery need to chang treatment; Participants drop out or death.
Intervention code [1] 286039 0
Treatment: Surgery
Intervention code [2] 286095 0
Treatment: Devices
Comparator / control treatment
Standard anti-tuberculous drug treatment alone
drugs involved:Isoniazide(H), Rifampicin(R),Pyrazinamide(Z) ,Ethambutol(E)
dosage amount and dosage frequency:Isoniazide(H), 300mg or 5mg/kg when weight less than 50kg;Rifampicin(R), 600mg or 10mg/kg when weight less than 50kg;Pyrazinamide(Z), 1500mg when weightless than 50kg;2000mg/d when weight greater than or equal to 50kg but less than75kg;2500mg/d when weight greater than or equal to 75kg;Ethambutol(E),25mg/kg, no more than 2000mg a day . The above data are dose for each time.
2HRZ/4HR means initial 2-month intensive phase of treatment with three or four daily rifampicin, isoniazid, pyrazinamide and ethambutol and followed by a 4-month continuation phase with only rifampicin and isoniazid thrice weekly.
mode of drug administration:oral
Duration:6 months.
Mode of follow-up management:
Beginning standard anti-tuberculous drug treatment;
3 months later:Follow-up visit to review;
6 months later: Ending drug treatment ,review;
9 months later: Follow-up visit to review;
12 months later: Follow-up visit to review;
18 months later: Follow-up visit to review;
24 months later: The last follow-up visit to review;
Participants will be followed as the above schedule till meeting follow-up endpoint events.
Items for review include computed tomography (CT), plain film of kidney-ureter-bladder and intravenous pyelography(KUB+IVU), ultrasound, radionuclide imaging, urine routine , erythrocyte sedimentation rate(ESR)and acid-fast bacilli in urine.
End point events include: kidney removed; a sever complication occurred due to drugs or surgery need to chang treatment; Participants drop out or death.
Control group
Active

Outcomes
Primary outcome [1] 288337 0
renal function
Timepoint [1] 288337 0
At 3,6 ,9,12,18,24months after starting chemotherapy.
Renal function assessed by radionuclide imaging , computed tomography (CT), plain film of kidney-ureter-bladder and intravenous pyelography(KUB+IVU), and ultrasound. It will be compared with the results of last time.
Primary outcome [2] 288339 0
Final kidney removal rate
Timepoint [2] 288339 0
At 3,6 ,9,12,18,24months after starting chemotherapy.
Nephrectomy when: a nonfunctioning kidney with or without calcification; extensive disease involving the whole kidney together with hypertension and ureteropelvic junction(UPJ) obstruction; and coexisting renal carcinoma.
radionuclide imaging , computed tomography(CT) , plain film of kidney-ureter-bladder and intravenous pyelography(KUB+IVU), and ultrasound will be used to assess renal filtration function , structure damage and coexistence of tumor lesions.
Primary outcome [3] 288340 0
TB control
Timepoint [3] 288340 0
At 3,6 ,9,12,18,24months after starting chemotherapy.

TB control assessed by patients symptom(such as night sweats, fever, weight loss, hematuresis and irritation sign of bladder) and auxiliary examination such as cystoscope, chest X-ray, plain film of kidney-ureter-bladder and intravenous pyelography(KUB+IVU),erythrocyte sedimentation rate(ESR),urine routine,PCR-TB-DNA and urine acid fast bacilli smear and culture.
Secondary outcome [1] 299907 0
Complication
Timepoint [1] 299907 0
Complication mainly include surgery-related complication, such as ureteral perforation, ureteral avulsion, failed to place double J stent.

Complication assessed when every time to operate (cystoscope or ureteroscope) .
When complication occurs during procedure , Operator will be aware of instantly with his experience.

Eligibility
Key inclusion criteria
Renal tuberculosis diagnosed by urine acid fast bacilli culture, PCR-TB-DNA or pathologic examination.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
renal atrophy , severe hydronephrosis, kidney empyemata,or non-functioning kidneys;
With contraindication of general anesthesia;
have been accepted tuberculosis treatment more than 2 weeks before or treatment drug include streptomycin;
Complicated cases ( recurrences of tuberculosis, immunosuppression and HIV/Aids).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
serially numbered, opaque, sealed envelopes.When researchers identified the conformity of subjects, the envelopes are opened and the subjects are assigned to the corresponding test group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
enter the website which is 'http://www.random.org/integers' to get the computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 4664 0
China
State/province [1] 4664 0
shanghai

Funding & Sponsors
Funding source category [1] 286303 0
Self funded/Unfunded
Name [1] 286303 0
Country [1] 286303 0
China
Primary sponsor type
Hospital
Name
shanghai changhai hopital
Address
Department of Urology, Changhai Hospital, Second Military Medical University,168 Changhai road yangpu district Shanghai 200433
Country
China
Secondary sponsor category [1] 285092 0
None
Name [1] 285092 0
Address [1] 285092 0
Country [1] 285092 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288375 0
Changhai Hospital Ethics Committee
Ethics committee address [1] 288375 0
Ethics committee country [1] 288375 0
China
Date submitted for ethics approval [1] 288375 0
10/10/2012
Approval date [1] 288375 0
Ethics approval number [1] 288375 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34906 0
Address 34906 0
Country 34906 0
Phone 34906 0
Fax 34906 0
Email 34906 0
Contact person for public queries
Name 18153 0
gaoxu
Address 18153 0
Department of Urology, Changhai Hospital, Second Military Medical University168 Changhai road yangpu district Shanghai(200433)
Country 18153 0
China
Phone 18153 0
+86 021 311 61718
Fax 18153 0
Email 18153 0
gaoxu.changhai@gmail.com
Contact person for scientific queries
Name 9081 0
Wang Hai-feng
Address 9081 0
Department of Urology, Changhai Hospital, Second Military Medical University168 Changhai road yangpu district Shanghai(200433)
Country 9081 0
China
Phone 9081 0
+86 021 311 61718
Fax 9081 0
Email 9081 0
whfcmm91@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.