Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
16 December 2017 |
Main ID: |
NCT01093157 |
Date of registration:
|
24/03/2010 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
A Dose Escalation Study of Long-acting ACTH Gel in Membranous Nephropathy
|
Scientific title:
|
A Dose-finding Pilot Study of ACTH (Adrenocorticotropic Hormone) on the Proteinuria and Serum Lipoprotein Profile in Patients With Idiopathic Membranous Nephropathy (MN) |
Date of first enrolment:
|
February 2010 |
Target sample size:
|
10 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT01093157 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
Phase:
|
Phase 1/Phase 2
|
|
Countries of recruitment
|
Canada
| | | | | | | |
Contacts
|
Name:
|
Daniel Cattran, M.D |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
University Health Network, Toronto |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:• Idiopathic MN with diagnostic biopsy performed less than 36 months
from the time of dose randomization.
- Patients need to be treated with an ACEI and/or ARB, for at least 3 months prior to
ACTH treatment and have adequately controlled blood pressure (BP <130/75 mm Hg in >75%
of the readings). Patients with documented evidence of >3 months treatment with
maximal Ang II blockade, target BP (BP <130/75 mm Hg in >75% of the readings) and who
remain with proteinuria >4.0g/24h may enter the ACTH phase of the study without the
need to have the run-in/conservative phase of the study.
- Proteinuria as measured by Uprot/Ucr > 4.0 on a spot sample aliquot from a 24-hour
urine collection. The choice of Uprot/UCr is in accord with recent NKF-CKD
guidelines.[9]
- Estimated GFR = 40 ml/min/1.73m2 while taking ACEI/ARB therapy. The GFR will be
estimated using the 4 variable MDRD equation as published in the NKF-CKD
guidelines.[9] The same NKF-CKD guidelines also promote the use of estimated GFR
(GFRest) values rather than serum creatinine levels or CrCl measurements as the
preferred non-invasive method of determining glomerular filtration rates.[9]
Exclusion Criteria:• Age <18 years.
- Estimated GFR < 40 ml/min/1.73m2, or serum creatinine >2.0 mg/dl.
- Renal biopsy showing more than 30% glomerulosclerosis and/or tubular atrophy.
- Patient must be off glucocorticoid, calcineurin inhibitors (cyclosporin A, tacrolimus)
or mycophenolic mofetil for > 1 month, and alkylating agents or rituximab for >6
months.
- Resistance to the following immunosuppressive routines e.g. steroids alone,
calcineurin inhibitors plus or minus steroids, cytotoxic agents plus or minus
steroids.
- Patients with active infections or secondary causes of MN (e.g. hepatitis B, SLE,
medications, malignancies). Testing for HIV, Hepatitis B and C should have occurred <
2 years prior to enrollment into the study.
- Type 1 or 2 diabetes mellitus: to exclude proteinuria secondary to diabetic
nephropathy. Patients who have recent history of steroid induced diabetes but no
evidence on renal biopsy performed within 6 months of entry into the study are
eligible for enrollment.
- Pregnancy or nursing - for safety reasons.
- Acute renal vein thrombosis documented prior to entry by renal US or CT scan and
requiring anticoagulation therapy.
Age minimum:
18 Years
Age maximum:
72 Years
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Glomerulonephritis
|
Intervention(s)
|
Drug: Adrenocorticotrophic hormone ACTH
|
Primary Outcome(s)
|
change in proteinuria from baseline to value at 3 months .
[Time Frame: 3 months]
|
Secondary Outcome(s)
|
Adverse effects
[Time Frame: Throughout three months of this study and for nine months follow-up]
|
Complete Remission(CR) or Partial Remission (PR) at 3 months
[Time Frame: 3 months]
|
Secondary ID(s)
|
Health Canada
|
08-006328-GN
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|