Idiopathic Membranous NephropathyPhase 2ACTHiMeNNCT00694863
Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy
A Phase 2 study testing tetracosactide hexacetaat in people with Idiopathic Membranous Nephropathy, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether treatment with long-acting synthetic adrenocorticotropic hormone is in the treatment of patients with idiopathic membranous nephropathy and high for renal failure. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Idiopathic Membranous Nephropathy
- What is being tested?
- tetracosactide hexacetaat
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2008to Dec 2012
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven idiopathic membranous nephropathy.
- Nephrotic syndrome: proteinuria > 3.5 g/day and serum albumine < 30 g/l
- Normal or mildly impaired renal function (eGFR > 60 ml/min, MDRD formula)
- High risk for renal failure: beta-2-microglobulin excretion > 500 ng/min
- Relative contra-indication for cyclophosphamide treatment:
- fertility and wish for (future) family expanding
Show all 9Show fewer
- high age ( > 60 years)
- former cyclophosphamide treatment
- intolerance to cyclophosphamide
Who cannot join
- Clinical,biochemical or histological signs of any underlying systemic disease
- Any infectious disease (including latent tuberculosis and/or latent amoebiasis)
- Active gastric or duodenal ulcers
- Pregnancy, lactation, inadequate contraceptives
- Clinical signs of renal vein thrombosis
- Asthma and /or any allergic conditions or hypersensitivity reactions
- Allergic reaction to synthetic ACTH in the past
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot Study
The purpose of this study is to determine whether treatment with long-acting synthetic adrenocorticotropic hormone is in the treatment of patients with idiopathic membranous nephropathy and high for renal failure.
- Conditions
- Idiopathic Membranous Nephropathy
- Being tested
- tetracosactide hexacetaat
- Keywords
- high risk for ESRD, immunosuppressive treatment, membranous nephropathy, ACTH
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tetracosactide hexacetaatDrug
Also called Synacthen Depot, long-acting synthetic ACTH
Intramuscular injections with tetracosactide hexacetaat (Synacthen Depot) 1ml a 1mg/ml. Treatment for 9 months with an increasing dosage from once per 2 weeks to twice a week.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | In this open-label study all patients included are treated in the experimental group. Receives: Drug: tetracosactide hexacetaat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attainability of ACTH therapy with intramuscular injections twice a week for a period of 9 months, measured as the percentage of injections that has been received in line with the treatment schedule.
Measured: 9 months
Secondary outcomes (1)
Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment
Measured: 9 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Kidney Foundation
- Responsible party
- Sponsor
- Investigators
- Jack FM Wetzels, M.D.Ph.D., Study director, Department of Nephrology, Radboud UniversityJulia M Hofstra, M.D., Principal investigator, Department of Nephrology, Radboud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694863
- Sponsor's protocol ID
- 2008.1
- Other IDs
- ABR: NL22482.091.08, CMO: 2008/77
- Acronym
- ACTHiMeN
- Status last verified
- Dec 2010
- First submitted
- 9 Jun 2008
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
van de Logt AE, Beerenhout CH, Brink HS, van de Kerkhof JJ, Wetzels JF, Hofstra JM. Synthetic ACTH in High Risk Patients with Idiopathic Membranous Nephropathy: A Prospective, Open Label Cohort Study. PLoS One. 2015 Nov 12;10(11):e0142033. doi: 10.1371/journal.pone.0142033. eCollection 2015.
PubMed 26562836
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot Study
- ClinicalTrials.gov ID
- NCT00694863
- Acronym / sponsor ID
- ACTHiMeN / 2008.1
- Conditions
- Idiopathic Membranous Nephropathy
- Keywords
- high risk for ESRD, immunosuppressive treatment, membranous nephropathy, ACTH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Kidney Foundation
- Study start
- Jul 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Jun 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.
The purpose of this study is to determine whether treatment with long-acting synthetic adrenocorticotropic hormone is in the treatment of patients with idiopathic membranous nephropathy and high for renal failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tetracosactide hexacetaatIn this open-label study all patients included are treated in the experimental group. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Biopsy-proven idiopathic membranous nephropathy.
- Nephrotic syndrome: proteinuria > 3.5 g/day and serum albumine < 30 g/l
- Normal or mildly impaired renal function (eGFR > 60 ml/min, MDRD formula)
- High risk for renal failure: beta-2-microglobulin excretion > 500 ng/min
- Relative contra-indication for cyclophosphamide treatment:
Key exclusion criteria (7 listed)
- Clinical,biochemical or histological signs of any underlying systemic disease
- Any infectious disease (including latent tuberculosis and/or latent amoebiasis)
- Active gastric or duodenal ulcers
- Pregnancy, lactation, inadequate contraceptives
- Clinical signs of renal vein thrombosis
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 |
|---|---|---|
| tetracosactide hexacetaatAlso: Synacthen Depot, long-acting synthetic ACTHIntramuscular injections with tetracosactide hexacetaat (Synacthen Depot) 1ml a 1mg/ml. Treatment for 9 months with an increasing dosage from once per 2 weeks to twice a week. | Drug | 1 |
Primary outcome
Attainability of ACTH therapy with intramuscular injections twice a week for a period of 9 months, measured as the percentage of injections that has been received in line with the treatment schedule.
Time frame: 9 months
1 secondary outcome
Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment
Time frame: 9 and 24 months
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 7 Jan 2013.
- Derived from this study: PubMed 26562836van de Logt AE, Beerenhout CH, Brink HS, van de Kerkhof JJ, Wetzels JF, Hofstra JM. Synthetic ACTH in High Risk Patients with Idiopathic Membranous Nephropathy: A Prospective, Open Label Cohort Study. PLoS One. 2015 Nov 12;10(11):e0142033. doi: 10.1371/journal.pone.0142033. eCollection 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.
Jack FM Wetzels, M.D.Ph.D. study director
Department of Nephrology, Radboud University
Julia M Hofstra, M.D. principal investigator
Department of Nephrology, Radboud University
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 tetracosactide hexacetaat in people with Idiopathic Membranous Nephropathy, run by Radboud University Medical Center at 1 site in Netherlands.
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 9 inclusion and 7 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 7 Jan 2013. 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 Netherlands. 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?
Attainability of ACTH therapy with intramuscular injections twice a week for a period of 9 months, measured as the percentage of injections that has been received in line with the treatment schedule. (time frame: 9 months). 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 NCT00694863, which also lists 1 linked publication.
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 7 Jan 2013.