Nephrotic SyndromePhase 2NCT00001212
Drug Therapy in Lupus Nephropathy
A Phase 2 study testing prednisone, cyclophosphamide and cyclosporin A in people with Nephrotic Syndrome and Systemic Lupus Erythematosus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Studies have shown that up to 26% of patients with systemic lupus erythematoses nephritis may suffer from membranous lupus nephropathy. The disease is characterized by high levels of protein in the urine and may eventually lead to kidney failure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nephrotic Syndrome, Systemic Lupus Erythematosus
- What is being tested?
- prednisone, cyclophosphamide and cyclosporin A
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1986to Sep 2004
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
INCLUSION CRITERIA - All patients admitted to the study must satisfy each of the following criteria:
Ability to provide informed consent to all aspects of the study after full information is provided.
SLE as defined by the presence of at least 4 criteria established by the American Rheumatism Association.
Age 12 years or older.
Membranous lupus nephropathy manifested by 2 or more grams per day of proteinuria in the absence of infection or recognized non-lupus renal disease. A renal biopsy must reveal typical membranous lupus nephropathy by light microscopy. Immune deposits must be predominately sub-epithelial and/or intramembranous in location by electron microscopy.
EXCLUSION CRITERIA - Patients with any one of the following conditions will be excluded:
Medication history of:
- cytotoxic drugs or cyclosporin A for more than 2 weeks during the 10 week period prior to study entry.
- cytotoxic drug therapy or cyclosporin A for more than 10 weeks at anytime in the past.
- cytotoxic drug therapy or cyclosporin A during the 30 day period prior to study entry.
- requirement of corticosteroids in doses greater than 20 mg/m(2)/day of prednisone (or equivalent) for control of extrarenal disease at the time of study entry.
Active acute or chronic infection requiring antimicrobial therapy, or serious viral infection (eg. hepatitis, herpes zoster).
Pregnant females, nursing mothers, or females not practicing birth control.
Patients with a single functioning kidney.
Pre-existent malignancy.
Insulin-treated diabetes mellitus.
GFR less than 25 ml/min/1.73m(2) BSA.
Known toxicity to cyclophosphamide.
Positive tests for HIV infection.
Furthermore, patients with any one of the following conditions (related to the use of cyclosporin A) will be excluded from randomization within renal function group 2 (Glomerular filtration rate greater than 66 ml/min/1.73m(2)):
- Renal biopsy revealing global sclerosis of greater than 50 percent of glomeruli, severe tubular atrophy, or severe interstitial fibrosis.
- Persistently abnormal and unexplained liver function abnormalities (defined as elevated transaminases, bilirubin, or alkaline phosphatase twice the upper limit of normal for at least 1 month) or evidence of active viral hepatitis.
- Hypertension difficult to control or uncontrollable with conventional anti-hypertensive regimens.
- Documented coronary artery disease.
- Convulsive disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, 20892
About this study
Official title: Immunosuppressive Drug Therapy in Membranous Lupus Nephropathy
Studies have shown that up to 26% of patients with systemic lupus erythematoses nephritis may suffer from membranous lupus nephropathy. The disease is characterized by high levels of protein in the urine and may eventually lead to kidney failure.
This study will evaluate the effectiveness and toxic effects of immunosuppressive drug therapy in patients with membranous lupus nephropathy over a 12 month period. The major goal of this therapy is to decrease protein losses and ultimately prevent kidney failure.
Read more
Patients enrolled in the study will undergo a routine history and physical examination. In addition, several diagnostic tests will be conducted including; chest x-ray ECG, blood and urine laboratory tests.
Patients will be divided and grouped according to the severity of their disease as shown by kidney function. Each group will then randomly be subcategorized by different treatment plans. Each treatment plan will made up of immunosuppressive medications including prednisone, cyclophosphamide, cyclosporin A, and combinations of these drugs. Patients will receive the medications as directed by the study.
The study will last 12 months and require patients to be admitted for two to five days before the study begins and once the study is completed. Patients will be followed as outpatients throughout the 12 month study.
Read the detailed description
This is a phase 2 trial to evaluate the effectiveness and toxicity of immunosuppressive drug therapy in patients with membranous lupus nephropathy over a 12 month study period. Patients with renal biopsy documented membranous nephropathy will all be treated with alternate day prednisone and will be randomized to receive: a) no additional therapy (control group), b) intravenous cyclophosphamide up to 1.0 gm per m(2) body surface area every other month for 6 total doses, or c) oral cyclosporin A up to 200 mg per m(2) body surface area daily for a total of 11 months. Patients with glomerular filtration rates 25-66 ml/min will be randomized only to prednisone alone or to prednisone plus cyclophosphamide. Renal function and disease activity will be monitored throughout the study; physiologic measures of glomerular function (GFR, permselectivity) will be examined at study entry and at the conclusion of the study. Comparison will be made of the number of favorable outcomes of glomerular function as well as drug related toxicities achieved by each treatment group at the end of the 12th study month.
- Conditions
- Nephrotic Syndrome, Systemic Lupus Erythematosus
- Being tested
- prednisone, cyclophosphamide, cyclosporin A
- Keywords
- Systemic Lupus Erythematosus, Nephrotic Syndrome, Immunosuppressive Drugs, Prednisone, Methylprednisolone, Cyclophosphamide, Cyclosporine, Cyclosporin A
- Medical subject headings
- Nephrotic Syndrome, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisoneDrug
cyclophosphamideDrug
cyclosporin ADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete or partial remission of proteinuria.
Measured: Within the firs year after starting protocol treatment
Secondary outcomes (3)
Change in glomerular filtration rate
Measured: One year
Adverse Effects
Measured: For the duration of extended follow-up starting at the beginning of protocol treatment
Time to relapse of nephritic syndrome
Measured: For the duration of extended follow-up starting at the end of the 12-month protocol treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startNov 1986
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 2
- Primary purpose
- Treatment
- Enrolment
- 45 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001212
- Sponsor's protocol ID
- 860204
- Other IDs
- 86-DK-0204
- Status last verified
- Apr 2008
- First submitted
- 3 Nov 1999
- Last updated
- 9 Apr 2008
- Results posted
- No
Publications
Donadio JV Jr, Burgess JH, Holley KE. Membranous lupus nephropathy: a clinicopathologic study. Medicine (Baltimore). 1977 Nov;56(6):527-36. doi: 10.1097/00005792-197711000-00007.
PubMed 916891Baldwin DS, Lowenstein J, Rothfield NF, Gallo G, McCluskey RT. The clinical course of the proliferative and membranous forms of lupus nephritis. Ann Intern Med. 1970 Dec;73(6):929-42. doi: 10.7326/0003-4819-73-6-929. No abstract available.
PubMed 4947941Baldwin DS, Gluck MC, Lowenstein J, Gallo GR. Lupus nephritis. Clinical course as related to morphologic forms and their transitions. Am J Med. 1977 Jan;62(1):12-30. doi: 10.1016/0002-9343(77)90345-x.
PubMed 835580
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunosuppressive Drug Therapy in Membranous Lupus Nephropathy
- ClinicalTrials.gov ID
- NCT00001212
- Acronym / sponsor ID
- 860204
- Conditions
- Nephrotic Syndrome, Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, Nephrotic Syndrome, Immunosuppressive Drugs, Prednisone, Methylprednisolone, Cyclophosphamide, Cyclosporine, Cyclosporin A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Nov 1986
- Study completion
- Sep 2004
- First posted
- 4 Nov 1999 (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.
Studies have shown that up to 26% of patients with systemic lupus erythematoses nephritis may suffer from membranous lupus nephropathy. The disease is characterized by high levels of protein in the urine and may eventually lead to kidney failure.
This study will evaluate the effectiveness and toxic effects of immunosuppressive drug therapy in patients with membranous lupus nephropathy over a 12 month period. The major goal of this therapy is to decrease protein losses and ultimately prevent kidney failure.
Patients enrolled in the study will undergo a routine history and physical examination. In addition, several diagnostic tests will be conducted including; chest x-ray ECG, blood and urine laboratory tests.
Patients will be divided and grouped according to the severity of their disease as shown by kidney function. Each group will then randomly be subcategorized by different treatment plans. Each treatment plan will made up of immunosuppressive medications including prednisone, cyclophosphamide, cyclosporin A, and combinations of these drugs. Patients will receive the medications as directed by the study.
The study will last 12 months and require patients to be admitted for two to five days before the study begins and once the study is completed. Patients will be followed as outpatients throughout the 12 month study.
Detailed description
This is a phase 2 trial to evaluate the effectiveness and toxicity of immunosuppressive drug therapy in patients with membranous lupus nephropathy over a 12 month study period. Patients with renal biopsy documented membranous nephropathy will all be treated with alternate day prednisone and will be randomized to receive: a) no additional therapy (control group), b) intravenous cyclophosphamide up to 1.0 gm per m(2) body surface area every other month for 6 total doses, or c) oral cyclosporin A up to 200 mg per m(2) body surface area daily for a total of 11 months. Patients with glomerular filtration rates 25-66 ml/min will be randomized only to prednisone alone or to prednisone plus cyclophosphamide. Renal function and disease activity will be monitored throughout the study; physiologic measures of glomerular function (GFR, permselectivity) will be examined at study entry and at the conclusion of the study. Comparison will be made of the number of favorable outcomes of glomerular function as well as drug related toxicities achieved by each treatment group at the end of the 12th study month.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 | Drug | – |
| cyclophosphamide | Drug | – |
| cyclosporin A | Drug | – |
Primary outcome
Time to complete or partial remission of proteinuria.
Time frame: Within the firs year after starting protocol treatment
3 secondary outcomes
Change in glomerular filtration rate
Time frame: One year
Adverse Effects
Time frame: For the duration of extended follow-up starting at the beginning of protocol treatment
Time to relapse of nephritic syndrome
Time frame: For the duration of extended follow-up starting at the end of the 12-month protocol treatment period
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 9 Apr 2008.
- Background: PubMed 916891Donadio JV Jr, Burgess JH, Holley KE. Membranous lupus nephropathy: a clinicopathologic study. Medicine (Baltimore). 1977 Nov;56(6):527-36. doi: 10.1097/00005792-197711000-00007.
- Background: PubMed 4947941Baldwin DS, Lowenstein J, Rothfield NF, Gallo G, McCluskey RT. The clinical course of the proliferative and membranous forms of lupus nephritis. Ann Intern Med. 1970 Dec;73(6):929-42. doi: 10.7326/0003-4819-73-6-929. No abstract available.
- Background: PubMed 835580Baldwin DS, Gluck MC, Lowenstein J, Gallo GR. Lupus nephritis. Clinical course as related to morphologic forms and their transitions. Am J Med. 1977 Jan;62(1):12-30. doi: 10.1016/0002-9343(77)90345-x.
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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 2 study testing prednisone, cyclophosphamide and cyclosporin A in people with Nephrotic Syndrome and Systemic Lupus Erythematosus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2008. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time to complete or partial remission of proteinuria. (time frame: Within the firs year after starting protocol treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001212, which also lists 3 linked publications.
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 9 Apr 2008.