Trial Outcomes & Findings for Angiotensin II Blockade for Chronic Allograft Nephropathy (NCT NCT00067990)

NCT ID: NCT00067990

Last Updated: 2017-09-18

Results Overview

Doubling of the interstitial or any defined ESRD (including IF/TA)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 153 participants
• Primary outcome timeframe: Baseline to 5 years
• Results posted on: 2017-09-18

Participant Flow

Participant milestones

Measure	Losartan 100 mg/day starting within three months of transplantation	Placebo starting within 3 months of transplantation
Overall Study STARTED	77	76
Overall Study COMPLETED	67	54
Overall Study NOT COMPLETED	10	22

Reasons for withdrawal

Measure	Losartan 100 mg/day starting within three months of transplantation	Placebo starting within 3 months of transplantation
Overall Study Death	5	7
Overall Study ESRD, Non IF/TA	1	3
Overall Study Withdrawal by Subject	4	12

Baseline Characteristics

Angiotensin II Blockade for Chronic Allograft Nephropathy

Baseline characteristics by cohort

Measure	Losartan n=77 Participants within 3 months of transplantation	Placebo n=76 Participants within 3 months of transplantation	Total n=153 Participants Total of all reporting groups
Age, Continuous	49.4 years STANDARD_DEVIATION 11.1 • n=5 Participants	48.0 years STANDARD_DEVIATION 13.6 • n=7 Participants	48.7 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	47 Participants n=7 Participants	94 Participants n=5 Participants
Race/Ethnicity, Customized White	66 Participants n=5 Participants	67 Participants n=7 Participants	133 Participants n=5 Participants
Race/Ethnicity, Customized Not Available	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Donor Type Live Donor	53 Participants n=5 Participants	55 Participants n=7 Participants	108 Participants n=5 Participants
Donor Type Cadaver Donor	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Cause of Native Kidney Disease Diabetes mellitus	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Cause of Native Kidney Disease Hypertension	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Cause of Native Kidney Disease Polycystic kidney disease	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Cause of Native Kidney Disease Other	28 Participants n=5 Participants	35 Participants n=7 Participants	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 5 years

Doubling of the interstitial or any defined ESRD (including IF/TA)

Outcome measures

Measure	Losartan n=48 Participants within 3 months of transplantation	Placebo n=47 Participants within 3 months of transplantation
Doubling of Interstitium or Any ESRD	6 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline and 5 Years Post Transplant

Population: Number of subjects who had baseline and exit biopsy samples that could be analyzed for doubling of cortical interstitial volume expansion or graft loss from IF/TA.

Number of subjects who had doubling of the interstitial or any end stage renal disease (ESRD) not attributed to interstitial fibrosis and tubular atrophy (IF/TA)

Outcome measures

Measure	Losartan n=47 Participants within 3 months of transplantation	Placebo n=44 Participants within 3 months of transplantation
Number of Participants With Cortical Interstitial Volume Expansion or Any ESRD	7 Participants	15 Participants

Adverse Events

Losartan

Serious events: 77 serious events

Other events: 35 other events

Deaths: 2 deaths

Placebo

Serious events: 76 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Losartan n=77 participants at risk within 3 months of transplantation	Placebo n=76 participants at risk within 3 months of transplantation
Infections and infestations Bacterial Infection	19.5% 15/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	19.7% 15/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Cardiac disorders Cardiovascular	11.7% 9/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	14.5% 11/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Gastrointestinal disorders Digestive	19.5% 15/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	23.7% 18/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Endocrine disorders Endocrine	13.0% 10/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	36.8% 28/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Infections and infestations Fungal/Other Infection	2.6% 2/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	7.9% 6/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Blood and lymphatic system disorders Hematologic	6.5% 5/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	13.2% 10/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Musculoskeletal and connective tissue disorders Musculoskeletal	24.7% 19/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	15.8% 12/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
General disorders	18.2% 14/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	13.2% 10/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Immune system disorders Rejection	15.6% 12/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	11.8% 9/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Respiratory, thoracic and mediastinal disorders Respiratory	9.1% 7/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	7.9% 6/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Renal and urinary disorders Urogenital	20.8% 16/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	34.2% 26/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Infections and infestations Viral Infection	7.8% 6/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	10.5% 8/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation

Other adverse events

Measure	Losartan n=77 participants at risk within 3 months of transplantation	Placebo n=76 participants at risk within 3 months of transplantation
Infections and infestations Bacterial infection	5.2% 4/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	6.6% 5/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Cardiac disorders Cardiovascular	0.00% 0/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	2.6% 2/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Gastrointestinal disorders Digestive	9.1% 7/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	5.3% 4/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Endocrine disorders Endocrine	0.00% 0/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	13.2% 10/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Infections and infestations Fungal/other infection	0.00% 0/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	2.6% 2/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Blood and lymphatic system disorders Hematologic	2.6% 2/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	6.6% 5/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Musculoskeletal and connective tissue disorders Musculoskeletal	6.5% 5/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	3.9% 3/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
General disorders Other/Unknown	3.9% 3/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	3.9% 3/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Immune system disorders Rejection	6.5% 5/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	1.3% 1/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Respiratory, thoracic and mediastinal disorders Respiratory	5.2% 4/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	1.3% 1/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Renal and urinary disorders Urogenital	5.2% 4/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	6.6% 5/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation
Infections and infestations Viral Infection	1.3% 1/77 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation	2.6% 2/76 • Subjects were randomized to treatment within three months of organ transplantation and data was collected from baseline to Year 5 post transplantation

Additional Information

Hassan N. Ibrahim, MD

University_of_Minnesota

Phone: (612) 624-9444

Email: ibrah007@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place