INNOVATION Study - Telmisartan (Micardis) in Incipient Diabetic Nephropathy

Diabetic Nephropathies Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled, Multicenter Trial to Investigate the Preventive Effect of BIBR277 (Telmisartan) in Diabetic Nephropathy on Transition From Incipient to Overt Nephropathy - Incipient to Overt : Angiotensin 2 Receptor Blocker, Telmisartan, Investigation on Type 2 Diabetic Nephropathy (INNOVATION Study -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153088
• Other study ID #: 502.413
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: October 31, 2013
• Start date: January 2003
• Est. completion date: November 2005

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the preventive effect of Telmisartan(Micardis) versus placebo control on the transition to overt nephropathy in patients with diabetic nephropathy manifesting microalbuminuria associated with type II diabetes, and to evaluate the efficacy and safety of Telmisart (Micardis, Gliosartan, Kinzal, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan) for diabetic nephropathy patients.

Description:

A prospective, randomised, double-blind, multicentric and comparative study to investigate, on a long-term basis, the preventive effect on the transition to overt nephropathy and the safety of Telmisartan (Micardis) against placebo in patients with diabetic nephropathy, manifesting microalbuminuria associated with type II diabetes.

Study Hypothesis:

The hypothesis is that Telmisartan (Micardis) at 40 mg or 80 mg versus placebo control in patients with concurrent type II diabetic mellitus or diabetic nephropathy demonstrating microalbuminuria, has the preventive effect on transition from incipient to overt nephropathy.

Comparison(s):

The primary endpoint is defined as the transition from incipient to overt nephropathy, and the non-transition curve will be demonstrated based on the Kaplan-Meier method. The evaluation criteria for the point to transition to overt nephropathy is defined as urinary albumin to creatinine ratios at consecutive 2 measuring points increasing over 300 mg/g-Creatinine and excess 30% increase comparing with the baseline value. The curve of non-transition will be compared with Logrank test. Those in BIBR277 groups are sequentially compared with that in the placebo group by the closed testing procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 527
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 74 Years

Eligibility

Inclusion Criteria:

1. Outpatients who are able to visit the study site throughout the run-in period

2. Aged 30 and 74 years

3. Type II diabetes mellitus

4. Patients with urinary albumin to creatinine ratios within the following ranges at 2 measuring points during the run-in period 1) the first-morning voided urine, iin the range of 100 to 300 mg/g Creatinine 2) < 100 mg/g Creatinine at either point of Visit 2 or 3, but in the range of 100 to 300 mg/g Creatinine at follow-up

5. Serum creatinine level of < 1.5 mg/dL in male and < 1.3 mg/dL in female

6. Normotensive or hypertensive patients

7. Patients taking AT1 antagonists or ACE inhibitors at screening, but are able to stop those drugs during the study

8. Patients who are able to provide written informed consent in accordance with the Good Clinical Practice (GCP) and other relevant laws such as the Pharmaceutical Affairs Law

Exclusion Criteria:

1. Age of onset of type 2 diabetes is < 30 years

2. Type I diabetes

3. Urinary albumin to creatinine ratio of > 300 mg/g Creatinine

4. HbA1c 9%

5. Seated SBP 180 mmHg or DBP 110 mmHg

6. Findings suggesting a renal disease other than diabetic nephropathy; such as post renal transplantation, history of non-diabetic renal disease, marked haematuria, complication of urinary tract infection

7. Cardiovascular diseases:

• Patients with unstable angina, myocardial infarction, CABG, PTCA within 6 months before

• CHF with NYHA III-IV

• TIA within 6 months

• Stroke within 6 months

• AV block (grade II-III) or AF

• Serious arrhythmia

• Known or suspected secondary HT

8. History of angioedema during administration of ARB/ACE-i

9. Hypersensitivity

10. History of sudden exacerbation of renal function due to ARB/ACE-i

11. Markedly poor bile secretion

12. Hepatic dysfunction: SGPT (ALT) or SGOT (AST) 100 IU/L

13. Serum potassium level < 3.5 mEq/L or 5.1 mEq/L

14. Unable to discontinue ARB/ACE-i

15. Require prolonged administration of any medications affecting blood pressure, except diuretics, or blockers, and CCB

16. Untreated sodium depletion

17. Pre-menopausal females who meet any one of the following:

• Pregnant or possibly pregnant

• Breast-feeding

• Hope to be pregnant during the study period

• Even when a patient is confirmed not to meet the above criteria at the start of the study, a female patient who has the potential to be pregnant during the study is to undergo pregnancy tests. If the result turns positive, the study medication should be discontinued.

18. Malignant tumour or other diseases requiring oral or injection immunosuppressants

19. Non-compliance

20. History of drug or alcohol abuse

21. Participated in other clinical studies within 3 months

22. Any other conditions investigators judged as ineligible

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• Telmisartan capsule 40 mg

• Placebo

• Telmisartan capsule 80 mg

Locations

Country	Name	City	State
Japan	Boehringer Ingelheim Investigational Site	Adachi-ku, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Amagasaki, Hyogo
Japan	Boehringer Ingelheim Investigational Site	Arakawa-ku, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Asaguchi-gun, Okayama
Japan	Boehringer Ingelheim Investigational Site	Asahi, Chiba
Japan	Boehringer Ingelheim Investigational Site	Asahikawa, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Asahikwa, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Atami, Shizuoka
Japan	Boehringer Ingelheim Investigational Site	Atsugi,Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Chikugo, Fukuoka
Japan	Boehringer Ingelheim Investigational Site	Chisagata-gun, Nagano
Japan	Boehringer Ingelheim Investigational Site	Chisagata-gun, Nagano
Japan	Boehringer Ingelheim Investigational Site	Chitose, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Chiyoda, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Chiyoda-ku, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Chiyoda-ku, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Ebina, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Fujisawa, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Fukuoka, Fukuoka
Japan	Boehringer Ingelheim Investigational Site	Fukuoka, Fukuoka
Japan	Boehringer Ingelheim Investigational Site	Fukuoka, Fukuoka
Japan	Boehringer Ingelheim Investigational Site	Fukuyama, Hiroshima
Japan	Boehringer Ingelheim Investigational Site	Funabashi, Chiba
Japan	Boehringer Ingelheim Investigational Site	Furukawa, Miyagi
Japan	Boehringer Ingelheim Investigational Site	Gifu, Gifu
Japan	Boehringer Ingelheim Investigational Site	Gobo, Wakayama
Japan	Boehringer Ingelheim Investigational Site	Hachioji, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Hakodate, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Hanamaki, Iwate
Japan	Boehringer Ingelheim Investigational Site	Hannan, Osaka
Japan	Boehringer Ingelheim Investigational Site	Hashima-gun, Gifu
Japan	Boehringer Ingelheim Investigational Site	Hatsukaichi, Hiroshima
Japan	Boehringer Ingelheim Investigational Site	Hirakata, Osaka
Japan	Boehringer Ingelheim Investigational Site	Hitachiota, Ibaragi
Japan	Boehringer Ingelheim Investigational Site	Ichinomiya, Aichi
Japan	Boehringer Ingelheim Investigational Site	Iida, Nagano
Japan	Boehringer Ingelheim Investigational Site	Ikeda, Osaka
Japan	Boehringer Ingelheim Investigational Site	Inashiki-gun, Ibaragi
Japan	Boehringer Ingelheim Investigational Site	Isehara, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Isezaki, Gunma
Japan	Boehringer Ingelheim Investigational Site	Itami, Hyogo
Japan	Boehringer Ingelheim Investigational Site	Izumisano, Osaka
Japan	Boehringer Ingelheim Investigational Site	Kamakura, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Kamakura, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Kamogawa, Chiba
Japan	Boehringer Ingelheim Investigational Site	Katsushika-ku, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Kawagoe, Saitama
Japan	Boehringer Ingelheim Investigational Site	Kawaguchi, Saitama
Japan	Boehringer Ingelheim Investigational Site	Kawasaki, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Kawasaki, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Kawasaki, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Kawasaki, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Kawasaki, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Kawasaki, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Kisarazu, Chiba
Japan	Boehringer Ingelheim Investigational Site	Kita-katushika-gun, Saitama
Japan	Boehringer Ingelheim Investigational Site	Kita-ku, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Kitami, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Kobe, Hyogo
Japan	Boehringer Ingelheim Investigational Site	Kobe, Hyogo
Japan	Boehringer Ingelheim Investigational Site	Kochi, Kochi
Japan	Boehringer Ingelheim Investigational Site	Kochi, Kochi
Japan	Boehringer Ingelheim Investigational Site	Kodaira, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Kodaira, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Komaki, Aichi
Japan	Boehringer Ingelheim Investigational Site	Komatsushima, Tokushima
Japan	Boehringer Ingelheim Investigational Site	Koriyama, Fukushima
Japan	Boehringer Ingelheim Investigational Site	Koriyama, Fukushima
Japan	Boehringer Ingelheim Investigational Site	Koriyama,Fukushima
Japan	Boehringer Ingelheim Investigational Site	Kounan, Aichi
Japan	Boehringer Ingelheim Investigational Site	Kumagaya, Saitama
Japan	Boehringer Ingelheim Investigational Site	Kurashiki, Okayama
Japan	Boehringer Ingelheim Investigational Site	Kurashiki, Okayama
Japan	Boehringer Ingelheim Investigational Site	Kyoto, Kyoto
Japan	Boehringer Ingelheim Investigational Site	Matsuyama, Ehime
Japan	Boehringer Ingelheim Investigational Site	Matsuyama, Ehime
Japan	Boehringer Ingelheim Investigational Site	Minato-ku, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Minato-ku, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Minato-ku, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Musashino, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	Boehringer Ingelheim Investigational Site	Nakano-ku, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Nangoku, Kochi
Japan	Boehringer Ingelheim Investigational Site	Nishinomiya, Hyogo
Japan	Boehringer Ingelheim Investigational Site	Nishinomiya, Hyogo
Japan	Boehringer Ingelheim Investigational Site	Nishinomiya, Hyogo
Japan	Boehringer Ingelheim Investigational Site	Noda, Chiba
Japan	Boehringer Ingelheim Investigational Site	Nomi, Ishikawa
Japan	Boehringer Ingelheim Investigational Site	Obihiro, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Odawara, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Oita, Oita
Japan	Boehringer Ingelheim Investigational Site	Okawa, Fukuoka
Japan	Boehringer Ingelheim Investigational Site	Okayama, Okayama
Japan	Boehringer Ingelheim Investigational Site	Okayama, Okayama
Japan	Boehringer Ingelheim Investigational Site	Okayama, Okayama
Japan	Boehringer Ingelheim Investigational Site	Osaka
Japan	Boehringer Ingelheim Investigational Site	Osaka, Osaka
Japan	Boehringer Ingelheim Investigational Site	Osaka, Osaka
Japan	Boehringer Ingelheim Investigational Site	Osaka, Osaka
Japan	Boehringer Ingelheim Investigational Site	Osaka-sayama, Osaka
Japan	Boehringer Ingelheim Investigational Site	Otaru, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Oyama, Tochigi
Japan	Boehringer Ingelheim Investigational Site	Sagamihara, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Sagamihara, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Sakai, Osaka
Japan	Boehringer Ingelheim Investigational Site	Sakai, Osaka
Japan	Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Sendai, Miyagi
Japan	Boehringer Ingelheim Investigational Site	Sendai, Miyagi
Japan	Boehringer Ingelheim Investigational Site	Setagaya-ku, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Seto, Aichi
Japan	Boehringer Ingelheim Investigational Site	Shibetsu, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Shibuya-ku, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Shibuya-ku, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Shinagawa, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Shinjuku-ku, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Shinjyuku-ku, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Shiojiri, Nagano
Japan	Boehringer Ingelheim Investigational Site	Sunagawa, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Takamatsu, Kagawa
Japan	Boehringer Ingelheim Investigational Site	Takarazuka, Hyogo
Japan	Boehringer Ingelheim Investigational Site	Takasaki, Gunma
Japan	Boehringer Ingelheim Investigational Site	Takatsuki, Osaka
Japan	Boehringer Ingelheim Investigational Site	Tama, Tokyo
Japan	Boehringer Ingelheim Investigational Site	Toride, Ibaraki
Japan	Boehringer Ingelheim Investigational Site	Tosu, Saga
Japan	Boehringer Ingelheim Investigational Site	Toyohashi, Aichi
Japan	Boehringer Ingelheim Investigational Site	Toyohashi, Aichi
Japan	Boehringer Ingelheim Investigational Site	Toyota, Aichi
Japan	Boehringer Ingelheim Investigational Site	Tsuchiura, Ibaraki
Japan	Boehringer Ingelheim Investigational Site	Tsuchiura,Ibaraki
Japan	Boehringer Ingelheim Investigational Site	Tsukuba, Ibaragi
Japan	Boehringer Ingelheim Investigational Site	Uji, Kyoto
Japan	Boehringer Ingelheim Investigational Site	Ushiku, Ibaraki
Japan	Boehringer Ingelheim Investigational Site	Uwajima, Ehime
Japan	Boehringer Ingelheim Investigational Site	Yokohama, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Yokohama, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Yokohama, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Yokohama, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Yokohama, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Yokohama, Kanagawa
Japan	Boehringer Ingelheim Investigational Site	Yokohama, Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-transition to overt nephropathy
Secondary	Change in renal parameters Composite endpoint

External Links

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