Contact information
Type
Scientific
Primary contact
Dr Anna-Lena Berg
ORCID ID
Contact details
Department of Nephrology
University Hospital in Lund
Lund
221 00
Sweden
+46 (0)46 17 22 57
Anna-Lena.Berg@njur.lu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Idiopathic membranous nephropathy is one of the most common causes of the nephrotic syndrome in adults. It leads to end-stage renal disease in roughly half of the patients. The disease is characterised by glomerular, subepithelial deposits which consist of immune complexes.
The hypothesis was that treatment with Adrenocorticotropic Hormone (ACTH) is superior to no specific treatment in nephrotic patients with idiopathic membranous nephropathy.
Ethics approval
The study was accepted by the Ethics Committees in Lund, Sweden (ref: LU 183-99) and Gothenburg, Sweden (ref: Gbg M056-99). The date of final acceptance was May 18, 1999.
Study design
Prospective, randomised, controlled, open-label interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Idiopathic membranous nephropathy
Intervention
The participants were randomised to treatment with Synacthen Depot or no specific treatment. Synacthen Depot is a depot preparation of a synthetic fragment of ACTH. The fragment consists of the first 24 amino acids of the native human peptide and it retains the adrenal activity. ACTH is formed in the pituitary gland. Its main action is the stimulation of the production/secretion of cortisol. The cortisol released by the actual dose of Synacthen Depot is not enough to explain an effect on membranous nephropathy. Thus, the mechanism of such an effect is unknown.
The dosage scheme of Synacthen Depot given subcutaneously was as follows:
Month one: 1.0 mg once a week
Month two: 0.75 mg twice a week
Months three to six: 1.0 mg twice a week
Month seven: 0.75 mg twice a week
Month eight: 1.0 mg once a week
Month nine: 0.5 mg once a week
Intervention type
Drug
Phase
Not Specified
Drug names
Adrenocorticotropic Hormone (ACTH) in the form of Synacthen Depot
Primary outcome measure
The primary outcomes were complete remissions and the combination of complete and partial remissions at the end of the treatment period (nine months after study start) and at the end of the follow-up period (21 months after study start).
A complete remission was defined as urinary albumin excretion less than 200 mg/24 hours and a partial remission was defined as urinary albumin excretion less than 2000 mg/24 hours in combination with a reduction of at least 50%.
Secondary outcome measures
The secondary outcomes were the changes at the end of the treatment period and the end of the follow-up period, as compared to baseline, in the serum concentrations of albumin, creatinine, apolipoprotein A1, apolipoprotein B and lipoprotein(a), the urinary excretion/24 hours of albumin, immunoglobulin G and protein HC, glomerular filtration rate and mean arterial pressure.
Overall trial start date
06/07/1999
Overall trial end date
31/01/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Males and females
2. Age 18 to 90
3. Membranous nephropathy according to kidney biopsy
4. Proteinuria of the nephrotic range for at least six months
5. Treatment with a statin and an angiotensin converting enzyme inhibitor for at least three months
6. Urinary albumin excretion more than 3000 mg/24 hours
7. Serum albumin concentration less than 26 g/L
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Thirty
Participant exclusion criteria
1. Moderate or heavy tubulointerstitial changes in the kidney biopsy
2. A recognisable cause of the nephrotic syndrome
3. Previous immunosuppressive treatment for the membranous nephropathy
4. Allergy to Synacthen Depot
5. Severe psychiatric disease
6. Pregnancy
7. History of noncompliance
Recruitment start date
06/07/1999
Recruitment end date
31/01/2005
Locations
Countries of recruitment
Sweden
Trial participating centre
Department of Nephrology
Lund
221 00
Sweden
Sponsor information
Organisation
Department of Nephrology, University Hospital in Lund (Sweden)
Sponsor details
Getingevägen 4
Lund
221 00
Sweden
+46 (0) 46 17 12 47
kerstin.wihlborg@med.lu.se
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Department of Medicine of the University in Lund (Sweden) (ref: M: B 39 422/01, M: B 19 1036/03, M: B 1002/04)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Federation of Swedish County Councils, Region Skane (Sweden) (ref: Lf 1297/00)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Department of Nephrology, University Hospital in Lund (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Department of Nephrology, Sahlgren´s University Hospital, Gothenburg (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list