IgA NephropathyPhase 3NCT00599963
Paricalcitol for the Treatment of Immunoglobulin A Nephropathy
A Phase 3 study testing paricalcitol in people with IgA Nephropathy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Immunoglobulin A (IgA) nephropathy is the common type of primary glomerulonephritis in the world. A wealth of literature suggests that vitamin D and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- paricalcitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2008to Dec 2009
- Phase
- Phase 3
- 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
- aged 18-65 years
- biopsy-confirmed IgA nephropathy
- proteinuria > 1 g/day (or proteinuria > 1 g/g-Cr) in 3 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment (e.g. ramipril 5 mg daily, lisinopril 10 mg daily, or valsartan 80 mg daily) for at least 3 months
- estimated glomerular filtration rate > 60 ml/min/1.73m2
- corrected serum calcium level > or = 2.45 mmol/l
- willingness to give written consent and comply with the study protocol
Who cannot join
- Pregnancy, lactating or childbearing potential without effective method of birth control
- Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
- History of malignancy, including leukemia and lymphoma within the past 2 years
- Systemic infection requiring therapy at study entry
- Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
- History of drug or alcohol abuse within past 2 years
Show all 13Show fewer
- Participation in any previous trial on paricalcitol
- Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 3 months
- Patients receiving treatment of corticosteroid
- On other investigational drugs within last 30 days
- History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
- History of non-compliance
- Known history of sensitivity or allergy to paricalcitol or other vitamin D analogs
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Medicine & Therapeutics, Prince of Wales Hospital
Shatin
About this study
Official title: Paricalcitol for the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study
Immunoglobulin A (IgA) nephropathy is the common type of primary glomerulonephritis in the world. A wealth of literature suggests that vitamin D and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. However, calcitriol, the standard form of vitamin D, carries a substantial risk of hypercalcemia. Recently, paricalcitol (19-nor-1,25-dihydroxyvitamin D2) was approved for the treatment of secondary hyperparathyroidism in chronic renal failure, and the incidence of hypercalcemia is much lower than calcitriol. Therefore, the investigators plan to conduct a randomized cross-over study to evaluate the efficacy of paricalcitol in the treatment of IgA nephropathy. Thirty patients with biopsy-proven IgA nephropathy will be recruited. They will be randomized to paricalcitol for 12 weeks or no treatment, followed by cross over to the other arm after a washout period. Proteinuria, renal function, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and anti-inflammatory effects of paricalcitol in the treatment of IgA nephropathy, which has no specific treatment at present.
- Conditions
- IgA Nephropathy
- Being tested
- paricalcitol
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paricalcitolDrug
paricalcitol 1 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | paricalcitol 1 mg/day for 12 weeks, followed by a washout period of 4 weeks, then crossed over to no treatment for another 12 weeks Receives: Drug: paricalcitol |
| 2 | Active comparator | no treatment for 12 weeks, followed by a washout period of 4 weeks, then crossed over to paricalcitol for another 12 weeks Receives: Drug: paricalcitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the degree of proteinuria
Measured: 12 weeks
Secondary outcomes (1)
rate of decline of estimated GFR (as determined by the least square method) and change in other serum inflammatory markers
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 posted24 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: Funding problem.
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 Chinese University of Hong KongThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Cheuk Chun Szeto, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599963
- Sponsor's protocol ID
- CRE-2007.409-T
- Other IDs
- CRE-2007.409-T
- Status last verified
- Jan 2009
- First submitted
- 2 Jan 2008
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paricalcitol for the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study
- ClinicalTrials.gov ID
- NCT00599963
- Acronym / sponsor ID
- CRE-2007.409-T
- Conditions
- IgA Nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding problem.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 24 Jan 2008 (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.
Immunoglobulin A (IgA) nephropathy is the common type of primary glomerulonephritis in the world. A wealth of literature suggests that vitamin D and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. However, calcitriol, the standard form of vitamin D, carries a substantial risk of hypercalcemia. Recently, paricalcitol (19-nor-1,25-dihydroxyvitamin D2) was approved for the treatment of secondary hyperparathyroidism in chronic renal failure, and the incidence of hypercalcemia is much lower than calcitriol. Therefore, the investigators plan to conduct a randomized cross-over study to evaluate the efficacy of paricalcitol in the treatment of IgA nephropathy. Thirty patients with biopsy-proven IgA nephropathy will be recruited. They will be randomized to paricalcitol for 12 weeks or no treatment, followed by cross over to the other arm after a washout period. Proteinuria, renal function, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and anti-inflammatory effects of paricalcitol in the treatment of IgA nephropathy, which has no specific treatment at present.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: paricalcitolparicalcitol 1 mg/day for 12 weeks, followed by a washout period of 4 weeks, then crossed over to no treatment for another 12 weeks |
| 2 | Active comparator | Drug: paricalcitolno treatment for 12 weeks, followed by a washout period of 4 weeks, then crossed over to paricalcitol for another 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 18-65 years
- biopsy-confirmed IgA nephropathy
- proteinuria > 1 g/day (or proteinuria > 1 g/g-Cr) in 3 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment (e.g. ramipril 5 mg daily, lisinopril 10 mg daily, or valsartan 80 mg daily) for at least 3 months
- estimated glomerular filtration rate > 60 ml/min/1.73m2
- corrected serum calcium level > or = 2.45 mmol/l
Key exclusion criteria (13 listed)
- Pregnancy, lactating or childbearing potential without effective method of birth control
- Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
- History of malignancy, including leukemia and lymphoma within the past 2 years
- Systemic infection requiring therapy at study entry
- Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
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 |
|---|---|---|
| paricalcitolparicalcitol 1 mg/day | Drug | 1, 2 |
Primary outcome
change in the degree of proteinuria
Time frame: 12 weeks
1 secondary outcome
rate of decline of estimated GFR (as determined by the least square method) and change in other serum inflammatory markers
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
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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.
Cheuk Chun Szeto, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing paricalcitol in people with IgA Nephropathy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 6 inclusion and 13 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: withdrawn, as of the sponsor's last update on 3 Aug 2015. 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 Hong Kong. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
change in the degree of proteinuria (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 3 Aug 2015.