Simple Renal CystNCT03259594
Measurement of Renal Functional Reserve Change In Patients With SRC Before and After Laparoscopic Deroofing
A study testing Laparoscopic deroofing and 100 g of amino acids supplementation in people with Simple Renal Cyst, run by ou tongwen at 1 site in China.
Trial summary
Renal functional reserve may be improved in patients with simple renal cysts after laparoscopic deroofing. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Simple Renal Cyst
- What is being tested?
- Laparoscopic deroofing and 100 g of amino acids supplementation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 31 Dec 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18
- Estimated GFR >30 mL/min/1.73m2
- Subjects who signed informed consent forms
Who cannot join
- Allergy to iothalamate, shellfish or iodine
- Use of metformin or amiodarone
- Inability to maintain a stable regimen of medications which affect GFR for > one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers)
- Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
- Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy
- Inadequate intravenous access
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- Severe anemia (Hct <21%)
- Acute kidney injury (rise in creatinine to ≥1.5 times the previous baseline or by ≥ 0.3 mg/dL on most recent labs prior to enrollment)
- History of contrast-induced nephropathy
- Hyperthyroidism
- Pheochromocytoma
- Sickle cell disease
- Urinary retention or incontinence
- Status post organ transplant
- Pregnancy or active breast feeding
- Cognitive impairment with inability to give consent
- Institutionalized status
Trial locations and contacts
1 site in 1 country.
Hao Yan, MD. contact
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Zhenhua Shang, MD.
About this study
Official title: Measurement of Renal Functional Reserve Change In Patients With Simple Renal Cysts Before and After Laparoscopic Deroofing
Renal functional reserve may be improved in patients with simple renal cysts after laparoscopic deroofing.
Read the detailed description
Simple renal cysts (SRC) are the most frequent type of cystic renal disease. The prevalence rate of SRCs is about 10% and increases with age. Hypertension and decreased renal functions have been reported to occur more commonly among these patients with SRC and there are no clear guidelines for managing asymptomatic SRCs.Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase glomerular filtration rate(GFR) from baseline in response to stimuli (e.g., protein load).The investigators hypothesized that RFR may be improved in some patients with simple renal cysts after laparoscopic deroofing despite identical resting glomerular filtration rate (rGFR).The aim of this study is to examine whether there is improvement of RFR in patients with simple renal cysts after laparoscopic deroofing.
- Conditions
- Simple Renal Cyst
- Being tested
- Laparoscopic deroofing, 100 g of amino acids supplementation
- Keywords
- Renal functional reserve, Simple renal cysts, Laparoscopic deroofing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic deroofingProcedure or surgery
The classic treatment of patients with simple renal cysts is deroofing, which can be performed by open surgery or laparoscopy. Laparoscopic deroofing is an effective minimally invasive approach and has gained popularity.
100 g of amino acids supplementationDrug
Also called Compound Amino Acids Injection(18AA-Ⅶ)
intravenous supplementation with 100 g of amino acids 2 day before laparoscopic deroofing.
| Study group | Role | What they receive |
|---|---|---|
| endophytic group | Experimental | participants are with endophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation. Receives: Procedure: Laparoscopic deroofing; Drug: 100 g of amino acids supplementation |
| exophytic group | Sham comparator | participants are with exophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation. Receives: Procedure: Laparoscopic deroofing; Drug: 100 g of amino acids supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in renal functional reserve after laparoscopic deroofing
1 month after surgery, repeated glomerular filtration rate measurements are to be performed to calculate change in renal functional reserve.
Measured: 1 month after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start1 Mar 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simple Renal CystStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to two groups.One group participants are with endophytic simple renal cysts, and the other are with exophytic simple renal cysts.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ou tongwen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ou tongwen, Xuanwu Hospital, Beijing
- Investigators
- Tongwen Ou, MD., Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259594
- Sponsor's protocol ID
- otw-20170804-01
- Status last verified
- Apr 2020
- First submitted
- 21 Aug 2017
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Renal Functional Reserve Change In Patients With Simple Renal Cysts Before and After Laparoscopic Deroofing
- ClinicalTrials.gov ID
- NCT03259594
- Acronym / sponsor ID
- otw-20170804-01
- Conditions
- Simple Renal Cyst
- Keywords
- Renal functional reserve, Simple renal cysts, Laparoscopic deroofing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- ou tongwenUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 Aug 2017 (actual)
- 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.
Renal functional reserve may be improved in patients with simple renal cysts after laparoscopic deroofing.
Detailed description
Simple renal cysts (SRC) are the most frequent type of cystic renal disease. The prevalence rate of SRCs is about 10% and increases with age. Hypertension and decreased renal functions have been reported to occur more commonly among these patients with SRC and there are no clear guidelines for managing asymptomatic SRCs.Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase glomerular filtration rate(GFR) from baseline in response to stimuli (e.g., protein load).The investigators hypothesized that RFR may be improved in some patients with simple renal cysts after laparoscopic deroofing despite identical resting glomerular filtration rate (rGFR).The aim of this study is to examine whether there is improvement of RFR in patients with simple renal cysts after laparoscopic deroofing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to two groups.One group participants are with endophytic simple renal cysts, and the other are with exophytic simple renal cysts.
| Arm | Type | Receives |
|---|---|---|
| endophytic group | Experimental | Procedure: Laparoscopic deroofing, Drug: 100 g of amino acids supplementationparticipants are with endophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation. |
| exophytic group | Sham comparator | Procedure: Laparoscopic deroofing, Drug: 100 g of amino acids supplementationparticipants are with exophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18
- Estimated GFR >30 mL/min/1.73m2
- Subjects who signed informed consent forms
Key exclusion criteria (17 listed)
- Allergy to iothalamate, shellfish or iodine
- Use of metformin or amiodarone
- Inability to maintain a stable regimen of medications which affect GFR for > one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers)
- Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
- Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy
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 |
|---|---|---|
| Laparoscopic deroofingThe classic treatment of patients with simple renal cysts is deroofing, which can be performed by open surgery or laparoscopy. Laparoscopic deroofing is an effective minimally invasive approach and has gained popularity. | Procedure or surgery | endophytic group, exophytic group |
| 100 g of amino acids supplementationAlso: Compound Amino Acids Injection(18AA-Ⅶ)intravenous supplementation with 100 g of amino acids 2 day before laparoscopic deroofing. | Drug | endophytic group, exophytic group |
Primary outcome
Change in renal functional reserve after laparoscopic deroofing
Time frame: 1 month after surgery.
1 month after surgery, repeated glomerular filtration rate measurements are to be performed to calculate change in renal functional reserve.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Hao Yan, MD. contact
Tongwen Ou, MD. study chair
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic deroofing and 100 g of amino acids supplementation in people with Simple Renal Cyst, run by ou tongwen at 1 site in China.
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 3 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 29 Apr 2020. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenhua Shang, MD. (+8617801117318, shangzhenhua16@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in renal functional reserve after laparoscopic deroofing (time frame: 1 month after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2020.