Condition category
Urological and Genital Diseases
Date applied
06/12/2006
Date assigned
26/01/2007
Last edited
26/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.skane.se/templates/Page.aspx?id=109334

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes