Protection Against Nephropathy in Diabetes with Atorvastatin
ISRCTN | ISRCTN58196433 |
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DOI | https://doi.org/10.1186/ISRCTN58196433 |
Secondary identifying numbers | N/A |
- Submission date
- 14/02/2008
- Registration date
- 21/04/2008
- Last edited
- 23/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Paul Durrington
Scientific
Scientific
Division of Cardiovascular and Endocrine Science
Core Technology Facility (3rd floor)
46 Grafton Street
Manchester
M13 9NT
United Kingdom
Phone | +44 (0)161 275 1201 |
---|---|
pdurrington@manchester.ac.uk |
Study information
Study design | A double-blinded parallel study, randomised by block design and stratified by centre. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Protection Against Nephropathy in Diabetes with Atorvastatin |
Study acronym | PANDA |
Study objectives | To compare the effect of treatment with a low and high dose HMG CoA reductase inhibitor on the progression of diabetic nephropathy in patients with type II diabetes whose blood pressure will be controlled using antihypertensive regimens that will include angiotensin II receptor antagonists. |
Ethics approval(s) | Central Manchester Research Ethics Committee. Date of approval: 28/07/2004 (ref: 04/Q1407/51) |
Health condition(s) or problem(s) studied | Type II diabetes with proteinuria |
Intervention | 1 x 10 mg active atorvastatin (oral) and 2 x 40 mg placebo vs 2 x 40 mg active atorvastatin (oral) and 1 x 10 mg placebo for three years. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Atorvastatin |
Primary outcome measure | 1. Difference in the mean level of glomerular filtration rates at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily 2. Difference in the mean level of albumin excretion rates at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily |
Secondary outcome measures | 1. Change in serum creatinine and GFR between baseline and 3 years follow-up for patients receiving atorvastatin 10 mg and 80 mg daily 2. Difference in the mean level of serum creatinine at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily 3. Difference in the percentage of patients achieving low density lipoprotein (LDL) cholesterol levels <2.6 mmol/l at 3 years follow-up between patients receiving atorvastatin 10 mg and 80 mg daily 4. Difference in the percentage of patients who have a cardiovascular event defined as documented non fatal acute myocardial infarction, hospital admission for unstable angina, appearance of new Q waves on electrocardiogram (ECG), coronary heart disease (CHD) death, coronary artery bypass surgery, coronary angioplasty/stenting or lower limb revascularisation, ischaemic stroke shown by abnormal brain scan or permanent neurological deficit, amputation 5. Difference in the percentage of patients who need photocoagulation for diabetic retinopathy within the first 3 years of follow-up between patients receiving atorvastatin 10 mg and 80 mg daily |
Overall study start date | 19/11/2004 |
Completion date | 30/06/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 200 |
Total final enrolment | 119 |
Key inclusion criteria | 1. Type 2 diabetes (defined according to the World Health Organization criteria) previously known to have proteinuria or microalbuminuria 2. Urinary albumin:creatinine ratio greater than 5 mg/mmol on two consecutive urine samples 3. Aged over 40 4. Capable of giving informed consent 5. Consent to inform General Practitioner of inclusion in study |
Key exclusion criteria | 1. Urinary protein output >2g/24 hours 2. Serum creatinine >= 200 µmol/l 3. Blood pressure >160/90 mmHg at randomisation 4. Women of child bearing potential 5. Serum cholesterol >= 7 mmol/l or fasting serum triglycerides >= 6 mmol/l at any visit 6. Taking >10 mg of atorvastatin at screening 7. Untreated hypothyroidism 8. Hepatic dysfunction, transaminase >2 times the upper limit of normal or alkaline phosphatase >1.5 times the upper limit of normal 9. Any other concomitant illness other than diabetes or its complication likely to effect outcome 10. Concomitant medication that may interact adversely with HMG-CoA reductase inhibitors or ATII receptor antagonists 11. Known intolerance of ATII receptor antagonists or HMG-CoA reductase inhibitors 12. HbA1c >10% at randomisation 13. Current participation in another clinical trial 14. Unable to comply with protocol for other reasons 15. Other lipid lowering medication at randomisation |
Date of first enrolment | 19/11/2004 |
Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Division of Cardiovascular and Endocrine Science
Manchester
M13 9NT
United Kingdom
M13 9NT
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
c/o Prof Paul Durrington
Division of Cardiovascular and Endocrine Science
Core Technology Facility (3rd floor)
46 Grafton Street
Manchester
M13 9NT
England
United Kingdom
Phone | 0161 275 1201 |
---|---|
pdurrington@manchester.ac.uk | |
Website | http://www.manchester.ac.uk |
https://ror.org/027m9bs27 |
Funders
Funder type
Industry
Pfizer UK Ltd (UK)
No information available
University of Manchester (Grant ref: R011264) (UK)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- The University of Manchester, University of Manchester UK, University of Manchester in United Kingdom, UoM
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/01/2011 | Yes | No | |
Results article | results | 01/01/2018 | 23/07/2019 | Yes | No |
Editorial Notes
23/07/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.