Treatment with adrenocorticotropic hormone in idiopathic membranous nephropathy
| ISRCTN | ISRCTN70791258 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70791258 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/12/2006
- Registration date
- 26/01/2007
- Last edited
- 26/01/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anna-Lena Berg
Scientific
Scientific
Department of Nephrology
University Hospital in Lund
Lund
221 00
Sweden
| Phone | +46 (0)46 17 22 57 |
|---|---|
| Anna-Lena.Berg@njur.lu.se |
Study information
| Study design | Prospective, randomised, controlled, open-label interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 06/07/1999 |
| Completion date | 31/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Thirty |
| Key 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 |
| Key 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 |
| Date of first enrolment | 06/07/1999 |
| Date of final enrolment | 31/01/2005 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department of Nephrology
Lund
221 00
Sweden
221 00
Sweden
Sponsor information
Department of Nephrology, University Hospital in Lund (Sweden)
Hospital/treatment centre
Hospital/treatment centre
Getingevägen 4
Lund
221 00
Sweden
| Phone | +46 (0) 46 17 12 47 |
|---|---|
| kerstin.wihlborg@med.lu.se | |
| Website | http://www.skane.se/templates/Page.aspx?id=109334 |
"ROR" |
https://ror.org/012a77v79 |
Funders
Funder type
Hospital/treatment centre
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)
No information available
The Federation of Swedish County Councils, Region Skane (Sweden) (ref: Lf 1297/00)
No information available
The Department of Nephrology, University Hospital in Lund (Sweden)
No information available
The Department of Nephrology, Sahlgren´s University Hospital, Gothenburg (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
