Type 2 Diabetic NephropathyPhase 4NCT03147677
Clinical Study of Treating Type 2 Diabetic Nephropathy With Alfacalcidol and Irbesartan
A Phase 4 study testing Alfacalcidol and Irbesartan in people with Type 2 Diabetic Nephropathy, run by The Third Xiangya Hospital of Central South University at 3 sites in China.
Trial summary
This is a prospective, multi-center, randomized, open-label, parallel-arm controlled study, for which a total of 216 patients with type 2 diabetic nephropathy (Stage II-IV) will be enrolled. The subjects will be randomized to three groups in 1:1:1 ratio. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetic Nephropathy
- What is being tested?
- Alfacalcidol and Irbesartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesChina
- Study dates
- 28 Jul 2016to 30 Dec 2018
- Phase
- Phase 4
- 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
- Adult Chinese subjects, at age 18-65, diagnosed with Type 2 diabetic nephropathy (Stage II-IV) who meet the WHO diagnostic standards of diabetes in 1999. The international Mogensen staging standard for diabetic nephropathy is used. Specifically, in Stage II (normal albuminuria stage), the UAER is normal (<20μg /min or<30mg/24h). In Stage III (early diabetic nephropathy stage), the UAER is 20-200μg /min or 30-300 mg/24h. In Stage IV (clinical or overt diabetic nephropathy stage), the UAER is >200μg/min or urine protein quantitation is >500mg /24h.
Who cannot join
- Renal damage caused by other causes;
- Uncontrolled hypertension (blood pressure constantly greater than 140/ 90mmHg);
- Type 1 Diabetes
- Any acute and chronic infections;
- Glycosylated hemoglobin (HbA1c)>7.5%;
- 24h urinary protein quantity>3g, serum albumin<25g /L and estimated glomerular filtration rate (eGFR)<60 ml/min;
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- Patients who suffered from malignant tumors or any illness that endanger life, such as liver, kidney, heart and lung function insufficiency over the past 5 years;
- People who have received the gastrointestinal operation, which may affect absorption of Vitamin D;
- People who have taken such drugs as angiotensin receptor blocker, calcium, and angiotensin converting enzyme inhibitor that affect excretion of urine protein, and who have been allergic to Vitamin D;
- Pregnant or lactating women;
- Other candidates that are deemed not suitable by investigators.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Hunan Chenzhou NO.1 People's Hospital
Chenzhou, Hunan, 423000
Hunan Yiyang Central Hospital
Yiyang, Hunan, 413000
About this study
Official title: A Prospective, Multi-center, Randomized, Open-label, Parallel-arm Controlled Study of Treating Type 2 Diabetic Nephropathy (Stage II-IV) With Alfacalcidol and Irbesartan
This is a prospective, multi-center, randomized, open-label, parallel-arm controlled study, for which a total of 216 patients with type 2 diabetic nephropathy (Stage II-IV) will be enrolled. The subjects will be randomized to three groups in 1:1:1 ratio. One group receive Alfacalcidol 0.25ug/day and Irbesartan 150mg/day for 16 consecutive weeks. The second group receive Alfacalcidol 0.25ug/day alone for 16 consecutive weeks. The third group receive Irbesartan 150mg/day alone for 16 consecutive weeks. All subjects will be followed up for 4 weeks after medication is over. A total of 4 visits have been scheduled for this study at week 0, week 8, week 16, week 20.
- Conditions
- Type 2 Diabetic Nephropathy
- Being tested
- Alfacalcidol, Irbesartan
- Keywords
- Type 2 diabetic nephropathy, Alfacalcidol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfacalcidolDrug
Also called Alfacalcidol Soft Capsules
IrbesartanDrug
Also called Irbesartan Pills
| Study group | Role | What they receive |
|---|---|---|
| Alfacalcidol and Irbesartan | Experimental | The subjects in this group orally take Alfacalcidol Soft Capsules at 0.25ug/day and Irbesartan Pills at 150mg/day for 16 consecutive weeks.All subjects will be followed up for 4 weeks after medication is over. A total of 4 visits have been scheduled for this study at week 0, week 8, week 16, week 20. Receives: Drug: Alfacalcidol; Drug: Irbesartan |
| Irbesartan | Active comparator | The subjects in this group orally take Irbesartan Pills at 150mg/day for 16 consecutive weeks.All subjects will be followed up for 4 weeks after medication is over. A total of 4 visits have been scheduled for this study at week 0, week 8, week 16, week 20. Receives: Drug: Irbesartan |
| Alfacalcidol | Active comparator | The subjects in this group orally takeAlfacalcidol Soft Capsules at 0.25ug/day for 16 consecutive weeks.All subjects will be followed up for 4 weeks after medication is over. A total of 4 visits have been scheduled for this study at week 0, week 8, week 16, week 20. Receives: Drug: Alfacalcidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 24h urinary albumin excretion rate (UAER) by comparing visits at week 20 with the baseline
Measured: at Week 20
Changes in 24h urinary protein quantity by comparing visits at week 20 with the baseline
Measured: at Week 20
Secondary outcomes (4)
Changes in estimated glomerular filtration rate (eGFR) by comparing visits at week 20 with the baseline
Measured: at Week 20
Changes in the urine levels of IL-6, MCP-1, TGF-β1, MIP-1β, and PTPN2 by comparing visits at week 20 with the baseline.
Measured: at Week 20
Changes in serum levels of IL-6, MCP-1, TGF-β1, MIP-1β, and PTPN2 by comparing visits at week 20 with the baseline.
Measured: at Week 20
Changes in urinary albumin / creatinine (UACR) of morning urine by comparing visits at week 20 with the baseline
Measured: at Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start28 Jul 2016
- Primary completion30 Jul 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Zhang, Doctor, Study chair, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147677
- Sponsor's protocol ID
- 320.6750.16025
- Status last verified
- May 2017
- First submitted
- 6 Apr 2017
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Open-label, Parallel-arm Controlled Study of Treating Type 2 Diabetic Nephropathy (Stage II-IV) With Alfacalcidol and Irbesartan
- ClinicalTrials.gov ID
- NCT03147677
- Acronym / sponsor ID
- 320.6750.16025
- Conditions
- Type 2 Diabetic Nephropathy
- Keywords
- Type 2 diabetic nephropathy, Alfacalcidol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 28 Jul 2016 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 10 May 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.
This is a prospective, multi-center, randomized, open-label, parallel-arm controlled study, for which a total of 216 patients with type 2 diabetic nephropathy (Stage II-IV) will be enrolled. The subjects will be randomized to three groups in 1:1:1 ratio. One group receive Alfacalcidol 0.25ug/day and Irbesartan 150mg/day for 16 consecutive weeks. The second group receive Alfacalcidol 0.25ug/day alone for 16 consecutive weeks. The third group receive Irbesartan 150mg/day alone for 16 consecutive weeks. All subjects will be followed up for 4 weeks after medication is over. A total of 4 visits have been scheduled for this study at week 0, week 8, week 16, week 20.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alfacalcidol and Irbesartan | Experimental | Drug: Alfacalcidol, Drug: IrbesartanThe subjects in this group orally take Alfacalcidol Soft Capsules at 0.25ug/day and Irbesartan Pills at 150mg/day for 16 consecutive weeks.All subjects will be followed up for 4 weeks after medication is over. A total of 4 visits have been scheduled for this study at week 0, week 8, week 16, week 20. |
| Irbesartan | Active comparator | Drug: IrbesartanThe subjects in this group orally take Irbesartan Pills at 150mg/day for 16 consecutive weeks.All subjects will be followed up for 4 weeks after medication is over. A total of 4 visits have been scheduled for this study at week 0, week 8, week 16, week 20. |
| Alfacalcidol | Active comparator | Drug: AlfacalcidolThe subjects in this group orally takeAlfacalcidol Soft Capsules at 0.25ug/day for 16 consecutive weeks.All subjects will be followed up for 4 weeks after medication is over. A total of 4 visits have been scheduled for this study at week 0, week 8, week 16, week 20. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Chinese subjects, at age 18-65, diagnosed with Type 2 diabetic nephropathy (Stage II-IV) who meet the WHO diagnostic standards of diabetes in 1999. The international Mogensen staging standard for diabetic nephropathy is used. Specifically, in Stage II (normal albuminuria stage), the UAER is normal (<20μg /min or<30mg/24h). In Stage III (early diabetic nephropathy stage), the UAER is 20-200μg /min or 30-300 mg/24h. In Stage IV (clinical or overt diabetic nephropathy stage), the UAER is >200μg/min or urine protein quantitation is >500mg /24h.
Key exclusion criteria (11 listed)
- Renal damage caused by other causes;
- Uncontrolled hypertension (blood pressure constantly greater than 140/ 90mmHg);
- Type 1 Diabetes
- Any acute and chronic infections;
- Glycosylated hemoglobin (HbA1c)>7.5%;
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 |
|---|---|---|
| AlfacalcidolAlso: Alfacalcidol Soft Capsules | Drug | Alfacalcidol, Alfacalcidol and Irbesartan |
| IrbesartanAlso: Irbesartan Pills | Drug | Alfacalcidol and Irbesartan, Irbesartan |
Primary outcome
Changes in 24h urinary albumin excretion rate (UAER) by comparing visits at week 20 with the baseline
Time frame: at Week 20
Changes in 24h urinary protein quantity by comparing visits at week 20 with the baseline
Time frame: at Week 20
4 secondary outcomes
Changes in estimated glomerular filtration rate (eGFR) by comparing visits at week 20 with the baseline
Time frame: at Week 20
Changes in the urine levels of IL-6, MCP-1, TGF-β1, MIP-1β, and PTPN2 by comparing visits at week 20 with the baseline.
Time frame: at Week 20
Changes in serum levels of IL-6, MCP-1, TGF-β1, MIP-1β, and PTPN2 by comparing visits at week 20 with the baseline.
Time frame: at Week 20
Changes in urinary albumin / creatinine (UACR) of morning urine by comparing visits at week 20 with the baseline
Time frame: at Week 20
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 Oct 2019.
- 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 Zhang, Doctor study chair
The Third Xiangya Hospital of Central South University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alfacalcidol and Irbesartan in people with Type 2 Diabetic Nephropathy, run by The Third Xiangya Hospital of Central South University at 3 sites 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 1 inclusion and 11 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 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in 24h urinary albumin excretion rate (UAER) by comparing visits at week 20 with the baseline (time frame: at Week 20). The study lists 2 primary outcomes in all. 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 10 Oct 2019.