Obesity and GlomerulopathyNCT02644486
A Prospective, Single-center, Randomized, Controlled Study of Sevelamer Carbonate in the Lipid Metabolism and Uric Acid Treatment of Obesity-Related Glomerulopathy
A study testing High dosage Sevelamer Carbonate + Irbesartan, Low dosage Sevelamer Carbonate + Irbesartan and Irbesartan in people with Obesity and Glomerulopathy, run by Zhi-Hong Liu, M.D. at 1 site in China.
Trial summary
To observe the decreased levels of low-density lipoprotein from baseline in patients with obesity-related glomerulopathy (ORG) after 12 weeks of Sevelamer Carbonate treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity and Glomerulopathy
- What is being tested?
- High dosage Sevelamer Carbonate + Irbesartan, Low dosage Sevelamer Carbonate + Irbesartan and Irbesartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Feb 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of obesity
- diagnosed ORG by renal biopsy
- LDL>3.37mmol/L
- Proteinuria 0.5-3.5g/d
- eGFR (CKD-EPI formula) > 30ml/min
Who cannot join
- Other concomitant renal diseases
- Endocrine or drug-induced obesity;
- Type 2 diabetes
- eyes or obvious microscopic hematuria;
- Swallowing difficulty / severe gastrointestinal dysfunction
- intestinal obstruction;
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- severe arrhythmia;
- Hypophosphatemia (<0.7mmol/L);
- allergic to Sevelamer Carbonate
- unable to well cooperate
- Females who are in the period of gestation or lactation, or refuse to use contraception;
- participated in other clinical trial of drug within three months
Trial locations and contacts
1 site in 1 country.
China1 site
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, 210002
About this study
To observe the decreased levels of low-density lipoprotein from baseline in patients with obesity-related glomerulopathy (ORG) after 12 weeks of Sevelamer Carbonate treatment.
- Conditions
- Obesity and Glomerulopathy
- Being tested
- High dosage Sevelamer Carbonate + Irbesartan, Low dosage Sevelamer Carbonate + Irbesartan, Irbesartan
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dosage Sevelamer Carbonate + IrbesartanDrug
Sevelamer Carbonate 4.8g/d+Irbesartan 300mg/d
Low dosage Sevelamer Carbonate + IrbesartanDrug
Sevelamer Carbonate 2.4g/d+Irbesartan 300mg/d
IrbesartanDrug
Irbesartan 300mg/d
| Study group | Role | What they receive |
|---|---|---|
| A Group | Experimental | Not described Receives: Drug: High dosage Sevelamer Carbonate + Irbesartan |
| B Group | Experimental | Not described Receives: Drug: Low dosage Sevelamer Carbonate + Irbesartan |
| C Group | Active comparator | Not described Receives: Drug: Irbesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
low-density lipoprotein
decreased levels of low-density lipoprotein from baseline
Measured: 12 weeks
Secondary outcomes (5)
uric acid
Changes of uric acid from baseline after 12 weeks of treatment
Measured: 12 weeks
blood lipids parameters (CHO, TG, HDL)
Changes of blood lipids parameters from baseline after 12 weeks of treatment
Measured: 12 weeks
proteinuria
Changes of proteinuria from baseline after 12 weeks of treatment
Measured: 12 weeks
blood glucose
Changes of blood glucose from baseline after 12 weeks of treatment
Measured: 12 weeks
glycated hemoglobin
Changes of glycated hemoglobin from baseline after 12 weeks of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: difficulty in enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and GlomerulopathyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhi-Hong Liu, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhi-Hong Liu, M.D., Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644486
- Sponsor's protocol ID
- NJCT-1406
- Status last verified
- Sep 2018
- First submitted
- 30 Dec 2015
- Last updated
- 2 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Randomized, Controlled Study of Sevelamer Carbonate in the Lipid Metabolism and Uric Acid Treatment of Obesity-Related Glomerulopathy
- ClinicalTrials.gov ID
- NCT02644486
- Acronym / sponsor ID
- NJCT-1406
- Conditions
- Obesity and Glomerulopathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Zhi-Hong Liu, M.D.University, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 31 Dec 2015 (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 decreased levels of low-density lipoprotein from baseline in patients with obesity-related glomerulopathy (ORG) after 12 weeks of Sevelamer Carbonate treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A Group | Experimental | Drug: High dosage Sevelamer Carbonate + Irbesartan |
| B Group | Experimental | Drug: Low dosage Sevelamer Carbonate + Irbesartan |
| C Group | Active comparator | Drug: Irbesartan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of obesity
- diagnosed ORG by renal biopsy
- LDL>3.37mmol/L
- Proteinuria 0.5-3.5g/d
- eGFR (CKD-EPI formula) > 30ml/min
Key exclusion criteria (12 listed)
- Other concomitant renal diseases
- Endocrine or drug-induced obesity;
- Type 2 diabetes
- eyes or obvious microscopic hematuria;
- Swallowing difficulty / severe gastrointestinal dysfunction
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 |
|---|---|---|
| High dosage Sevelamer Carbonate + IrbesartanSevelamer Carbonate 4.8g/d+Irbesartan 300mg/d | Drug | A Group |
| Low dosage Sevelamer Carbonate + IrbesartanSevelamer Carbonate 2.4g/d+Irbesartan 300mg/d | Drug | B Group |
| IrbesartanIrbesartan 300mg/d | Drug | C Group |
Primary outcome
low-density lipoprotein
Time frame: 12 weeks
decreased levels of low-density lipoprotein from baseline
5 secondary outcomes
uric acid
Time frame: 12 weeks
blood lipids parameters (CHO, TG, HDL)
Time frame: 12 weeks
proteinuria
Time frame: 12 weeks
blood glucose
Time frame: 12 weeks
glycated hemoglobin
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: difficulty in enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dosage Sevelamer Carbonate + Irbesartan, Low dosage Sevelamer Carbonate + Irbesartan and Irbesartan in people with Obesity and Glomerulopathy, run by Zhi-Hong Liu, M.D. 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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 2 Oct 2018. 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. 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 was stopped early (reason given: difficulty in enrollment). Results are not available in the source record.
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?
low-density lipoprotein (time frame: 12 weeks). 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 2 Oct 2018.