Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
14/07/2014
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

Prof R Bilous

ORCID ID

Contact details

South Cleveland Hospital
Audrey Collins Teaching Unit
Education Centre
Marton Road
Middlesborough
TS4 3BW
United Kingdom
+44 (0)1642 854 146
r.w.bilous@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0010

Study information

Scientific title

Acronym

ESPRIT

Study hypothesis

A multi-centre randomised double blind parallel group study evaluating the efficacy of Enalapril and Nifedipine retard and placebo on the evolution of the renal glomerular lesions of diabetic patients with increased urinary albumin excretion. To determine whether Enalapril (an ACE inhibitor) preferentially halts or reverses the progression of the glomerular lesions of diabetic nephropathy.

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised controlled double-blind parallel group study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Nutritional, metabolic and endocrine diseases: Diabetes

Intervention

Enalapril and nifedipine retard versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Enalapril and Nifedipine retard

Primary outcome measures

Whether Enalapril (an ACE inhibitor) preferentially halts or reverses the progression of the glomerular lesions of diabetic nephropathy.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

04/01/1993

Overall trial end date

31/03/1996

Reason abandoned

Eligibility

Participant inclusion criteria

Diabetic patients with increased urinary albumin excretion

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

04/01/1993

Recruitment end date

31/03/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Cleveland Hospital
Middlesborough
TS4 3BW
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (UK)

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

ESPRIT publications in http://www.ncbi.nlm.nih.gov/pubmed/10648672 and http://www.ncbi.nlm.nih.gov/pubmed/9150483

Publication citations

  1. Macleod JM, White KE, Tate H, Bilous RW, Measurement of glomerular volume in needle biopsy specimens. The ESPRIT Study Group (European Study of the Progression of Renal Disease in Type 1 Diabetes)., Nephrol. Dial. Transplant., 2000, 15, 2, 239-243.

  2. MacLeod JM, White KE, Tate H, Bilous RW, Efficient morphometric analysis of glomerular mesangium in insulin-dependent diabetic patients with early nephropathy. The European Study of the Progression of Renal Disease in Type 1 (Insulin Dependent) Diabetes (ESPRIT) Study Group., Kidney Int., 1997, 51, 5, 1624-1628.

Additional files

Editorial Notes