Diabetes, Type IPhase 4NCT00328302
Diabetes Type 1, Treatment Study Atacand/Placebo After Kidney Biopsy
A Phase 4 study testing Candesartan in people with Diabetes, Type I, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The type 1 diabetes patients who were still normoalbuminuric and normotensive, after 17 years duration and a second research kidney biopsy, could enter the double blind treatment study of Atacand or Placebo. The treatment study continues for five years treatment and ends with a third kidney biopsy. Read more about this study
- Who is it for?
- Ages 17 to 30 years
- Conditions the study is for
- Diabetes, Type I
- What is being tested?
- Candesartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2000to Apr 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diabetes type 1 patient
- Normotensive
- Normoalbuminuric
- Signed informed consent
- Female and male
- Over 17 years of age
- Diabetes duration over 10 years
Who cannot join
- Hypertension
- Microalbuminuria
- Pregnancy
- Lactation
- Reduced kidney function
- Artery stenosis
Show all 13Show fewer
- Kidney transplantation
- Allergy to the medication in the study
- Reduced liver function
- Alcohol or drug abuse
- Participation in another drug or clinical test during last 30 days
- Severe diseases i.e. malignancy
- Previously enrolment of the present study
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Childrens Hospital, Karolinska University Hospital, Huddinge
Stockholm, 141 86
About this study
Official title: Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology, Kidney Function and Metabolic Control. Natural History and Effect of ARB
The type 1 diabetes patients who were still normoalbuminuric and normotensive, after 17 years duration and a second research kidney biopsy, could enter the double blind treatment study of Atacand or Placebo.
The treatment study continues for five years treatment and ends with a third kidney biopsy.
The study hypothesis is that the effect of ARB during 5 years on the histopathology are more pronounced than the effect on histopathology of placebo.
Read the detailed description
46 patients performed a first kidney biopsy between 1992-1994. After 6 years 29 accepted to perform a second biopsy. During the follow-up 10 patients developed complications i.e. hypertension or microalbuminuria. 7 of the patients got treatment during follow up and 3 started the treatment after the second biopsy. 19 patients with two kidney biopsies were still normoalbuminuric and normotensive. 13 of them entered the double-blind treatment study of Atacand or Placebo. 6 denied to participate in the treatment study.
The treatment study will continue for 5 years and will end with a third kidney biopsy. Also the rest of the patients that have done 2 kidney biopsies will be asked to perform a third biopsy.
- Conditions
- Diabetes, Type I
- Being tested
- Candesartan, Placebo
- Keywords
- Diabetes, Kidney function, 24 ambulatory blood pressure, Kidney biopsy
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandesartanDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Basement membrane thickness
Mesangial expansion
Secondary outcomes (4)
Hypertension
Microalbuminuria
Kidney Function
24 hour ambulatory blood pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startSep 2000
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes, Type IStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 13 participants
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Nina ES Perrin, PhD-student, Principal investigator, Karolinska University Hospital, Huddinge, B57, Childrens Hospital, 141 86 StockholmUlla B Berg, Professor, Study director, Karolinska University Hospital, B57, Childrens Hospital, 141 86 Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328302
- Sponsor's protocol ID
- SH-AHM-0044-01
- Status last verified
- Jun 2000
- First submitted
- 18 May 2006
- Last updated
- 19 May 2006
- Results posted
- No
Publications
Perrin NE, Jaremko GA, Berg UB. The effects of candesartan on diabetes glomerulopathy: a double-blind, placebo-controlled trial. Pediatr Nephrol. 2008 Jun;23(6):947-54. doi: 10.1007/s00467-008-0745-x.
PubMed 18270751
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Early Diabetic Glomerulopathy-the Relation Between Histopathology, Kidney Function and Metabolic Control. Natural History and Effect of ARB
- ClinicalTrials.gov ID
- NCT00328302
- Acronym / sponsor ID
- SH-AHM-0044-01
- Conditions
- Diabetes, Type I
- Keywords
- Diabetes, Kidney function, 24 ambulatory blood pressure, Kidney biopsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Sep 2000
- Study completion
- Apr 2006
- First posted
- 19 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The type 1 diabetes patients who were still normoalbuminuric and normotensive, after 17 years duration and a second research kidney biopsy, could enter the double blind treatment study of Atacand or Placebo.
The treatment study continues for five years treatment and ends with a third kidney biopsy.
The study hypothesis is that the effect of ARB during 5 years on the histopathology are more pronounced than the effect on histopathology of placebo.
Detailed description
46 patients performed a first kidney biopsy between 1992-1994. After 6 years 29 accepted to perform a second biopsy. During the follow-up 10 patients developed complications i.e. hypertension or microalbuminuria. 7 of the patients got treatment during follow up and 3 started the treatment after the second biopsy. 19 patients with two kidney biopsies were still normoalbuminuric and normotensive. 13 of them entered the double-blind treatment study of Atacand or Placebo. 6 denied to participate in the treatment study.
The treatment study will continue for 5 years and will end with a third kidney biopsy. Also the rest of the patients that have done 2 kidney biopsies will be asked to perform a third biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 17 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Diabetes type 1 patient
- Normotensive
- Normoalbuminuric
- Signed informed consent
- Female and male
Key exclusion criteria (13 listed)
- Hypertension
- Microalbuminuria
- Pregnancy
- Lactation
- Reduced kidney function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candesartan | Drug | – |
| Placebo | Drug | – |
Primary outcome
Basement membrane thickness
Mesangial expansion
4 secondary outcomes
Hypertension
Microalbuminuria
Kidney Function
24 hour ambulatory blood pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2006.
- Derived from this study: PubMed 18270751Perrin NE, Jaremko GA, Berg UB. The effects of candesartan on diabetes glomerulopathy: a double-blind, placebo-controlled trial. Pediatr Nephrol. 2008 Jun;23(6):947-54. doi: 10.1007/s00467-008-0745-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina ES Perrin, PhD-student principal investigator
Karolinska University Hospital, Huddinge, B57, Childrens Hospital, 141 86 Stockholm
Ulla B Berg, Professor study director
Karolinska University Hospital, B57, Childrens Hospital, 141 86 Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Candesartan in people with Diabetes, Type I, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basement membrane thickness. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00328302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2006.