IgA NephropathyPhase 4e-TOPplusNCT03218852
Extended Follow-up of Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy
A Phase 4 study testing prednisone and cyclophosphamide and prednisone alone in people with IgA Nephropathy, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This study is an extended follow-up of the study (ClinicalTrials.gov ID: NCT01758120)-Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone alone in patients with advanced-stage IgA nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- prednisone and cyclophosphamide and prednisone alone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- biopsy-proven primary IgA nephropathy
- 18-70 years old
- elevated serum Creatinine and less than 3.0mg/dl
- with a written consent from participants to receive prednisone and/or cyclophosphamide
Who cannot join
- diabetes;
- contraindications for the treatment of prednisone and/or cyclophosphamide
- any treatment with steroids or immunosuppressive drugs prior to this study
- acute deterioration of renal function(including those of glomerular origin)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Extended Follow-up of the Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced Stage IgA Nephropathy
This study is an extended follow-up of the study (ClinicalTrials.gov ID: NCT01758120)-Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone alone in patients with advanced-stage IgA nephropathy.
- Conditions
- IgA Nephropathy
- Being tested
- prednisone and cyclophosphamide, prednisone alone
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisone and cyclophosphamideDrug
Prednisone and cyclophosphamide are both administered to participants in this group.
prednisone aloneDrug
Prednisone is administered to participants in this group.
| Study group | Role | What they receive |
|---|---|---|
| prednisone and cyclophosphamide | Experimental | 1. prednisone(0.5mg/kg/day*6 months)
2. cyclophosphamide(1g intravenous use,per 1 month*6months);
3. supportive care,including ACE-I or ARBs and blood pressure control Receives: Drug: prednisone and cyclophosphamide |
| prednisone alone | Experimental | 1. prednisone(0.5mg/kg/day*6months);
2. supportive care,including ACE-I or ARBs and blood pressure control Receives: Drug: prednisone alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes of kidney function or death
- addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of treatment
- the changes of estimated glomerular filtration rate (eGFR) or a combination of reaching end-stage renal disease (ESRD) or doubling of serum Creatinine or death
Measured: a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)
Secondary outcomes (2)
the changes of proteinuria
- addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of treatment
- the changes of proteinuria
Measured: a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)
Number of Participants with Adverse Events
- addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of treatment
- Number of Participants with Adverse Events; adverse events include hair loss, vomiting, diarrhea, jaundice, leukopenia, anemia, thrombocytopenia, infections, allergic reactions and hemorrhagic cystitis.
Measured: a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study startDec 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Shi, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218852
- Sponsor's protocol ID
- GGH2012-36-1
- Acronym
- e-TOPplus
- Status last verified
- Jul 2017
- First submitted
- 7 Dec 2016
- Last updated
- 17 Jul 2017
- Results posted
- 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 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extended Follow-up of the Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced Stage IgA Nephropathy
- ClinicalTrials.gov ID
- NCT03218852
- Acronym / sponsor ID
- e-TOPplus / GGH2012-36-1
- Conditions
- IgA Nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Jul 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 study is an extended follow-up of the study (ClinicalTrials.gov ID: NCT01758120)-Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone alone in patients with advanced-stage IgA nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prednisone and cyclophosphamide | Experimental | Drug: prednisone and cyclophosphamide1. prednisone(0.5mg/kg/day*6 months) 2. cyclophosphamide(1g intravenous use,per 1 month*6months); 3. supportive care,including ACE-I or ARBs and blood pressure control |
| prednisone alone | Experimental | Drug: prednisone alone1. prednisone(0.5mg/kg/day*6months); 2. supportive care,including ACE-I or ARBs and blood pressure control |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- biopsy-proven primary IgA nephropathy
- 18-70 years old
- elevated serum Creatinine and less than 3.0mg/dl
- with a written consent from participants to receive prednisone and/or cyclophosphamide
Key exclusion criteria (4 listed)
- diabetes;
- contraindications for the treatment of prednisone and/or cyclophosphamide
- any treatment with steroids or immunosuppressive drugs prior to this study
- acute deterioration of renal function(including those of glomerular origin)
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 |
|---|---|---|
| prednisone and cyclophosphamidePrednisone and cyclophosphamide are both administered to participants in this group. | Drug | prednisone and cyclophosphamide |
| prednisone alonePrednisone is administered to participants in this group. | Drug | prednisone alone |
Primary outcome
the changes of kidney function or death
Time frame: a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)
1. addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of treatment 2. the changes of estimated glomerular filtration rate (eGFR) or a combination of reaching end-stage renal disease (ESRD) or doubling of serum Creatinine or death
2 secondary outcomes
the changes of proteinuria
Time frame: a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)
Number of Participants with Adverse Events
Time frame: a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- 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.
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 Phase 4 study testing prednisone and cyclophosphamide and prednisone alone in people with IgA Nephropathy, run by Guangdong Provincial People's Hospital 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 4 inclusion and 4 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 17 Jul 2017. 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.
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?
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?
the changes of kidney function or death (time frame: a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)). 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 17 Jul 2017.