Trial Outcomes & Findings for A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters (NCT NCT00396032)

Last Updated: 2010-06-03

Results Overview

Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

150 participants

Primary outcome timeframe

Visit 1 of HD treatment

Results posted on

2010-06-03

Participant Flow

One participant was randomized but not treated, therefore the modified intent-to-treat (MITT) analysis population was 149.

Participant milestones

Participant milestones
Measure	Tenecteplase For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase	Placebo For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
Overall Study STARTED	74	76
Overall Study COMPLETED	70	71
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tenecteplase n=74 Participants For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase	Placebo n=75 Participants For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase	Total n=149 Participants Total of all reporting groups
Age, Customized < 17 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age, Customized >= 17 years to < 65 years	44 participants n=5 Participants	51 participants n=7 Participants	95 participants n=5 Participants
Age, Customized >= 65 years	30 participants n=5 Participants	24 participants n=7 Participants	54 participants n=5 Participants
Age Continuous	60.8 years STANDARD_DEVIATION 14.1 • n=5 Participants	57.8 years STANDARD_DEVIATION 16.5 • n=7 Participants	59.3 years STANDARD_DEVIATION 15.3 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	37 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 1 of HD treatment

Population: Modified intent to treat (MITT) population

Outcome measures

Outcome measures
Measure	Tenecteplase n=74 Participants For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase	Placebo n=75 Participants For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
Percentage of Subjects Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1	21.6 percentage of success	5.3 percentage of success

PRIMARY outcome

Timeframe: Visits 1 and 2 of consecutive HD treatments

Population: MITT population

Targeted AEs were intracranial hemorrhages (ICHs), major bleeding, embolic events, thrombosis, catheter-related bloodstream infections (CRBSIs), and catheter related complications

Outcome measures

Outcome measures
Measure	Tenecteplase n=74 Participants For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase	Placebo n=75 Participants For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
Incidence of Targeted Adverse Events (AEs) From Initial Study Drug Administration Through the Start of Visit 2 Intracranial hemorrhage	0 percentage of participants	0 percentage of participants
Incidence of Targeted Adverse Events (AEs) From Initial Study Drug Administration Through the Start of Visit 2 Major bleeding	0 percentage of participants	0 percentage of participants
Incidence of Targeted Adverse Events (AEs) From Initial Study Drug Administration Through the Start of Visit 2 Embolic event	0 percentage of participants	0 percentage of participants
Incidence of Targeted Adverse Events (AEs) From Initial Study Drug Administration Through the Start of Visit 2 Thrombosis	0 percentage of participants	0 percentage of participants
Incidence of Targeted Adverse Events (AEs) From Initial Study Drug Administration Through the Start of Visit 2 Catheter-related blood stream infection	0 percentage of participants	4.0 percentage of participants
Incidence of Targeted Adverse Events (AEs) From Initial Study Drug Administration Through the Start of Visit 2 Catheter-related complication	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Visit 1 of HD treatment

Population: MITT population

BFR is measured in mL/minute.

Outcome measures

Outcome measures
Measure	Tenecteplase n=74 Participants For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase	Placebo n=75 Participants For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
Change in BFR From Baseline to the End of HD at Visit 1 < 0 mL/min	8.1 percentage of participants 102.97	9.3 percentage of participants 55.98
Change in BFR From Baseline to the End of HD at Visit 1 0-24 mL/min	58.1 percentage of participants	80.0 percentage of participants
Change in BFR From Baseline to the End of HD at Visit 1 25-49 mL/min	8.1 percentage of participants	2.7 percentage of participants
Change in BFR From Baseline to the End of HD at Visit 1 50-99 mL/min	8.1 percentage of participants	4.0 percentage of participants
Change in BFR From Baseline to the End of HD at Visit 1 100-149 mL/min	5.4 percentage of participants	1.3 percentage of participants

SECONDARY outcome

Timeframe: Visit 2 of consecutive HD treatments

Population: MITT population with extended-dwell tenecteplase at Visit 1

Outcome measures

Outcome measures
Measure	Tenecteplase n=24 Participants For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase	Placebo n=39 Participants For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Extended Dwell Tenecteplase at Visit 1)	41.7 percentage of success	38.5 percentage of success

SECONDARY outcome

Timeframe: Visit 2 of consecutive HD treatments

Population: MITT population with open-label tenecteplase at Visit 2

Outcome measures

Outcome measures
Measure	Tenecteplase n=26 Participants For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase	Placebo n=23 Participants For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Open-label Tenecteplase at Visit 2)	11.5 percentage of success	34.8 percentage of success

Adverse Events

Tenecteplase

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tenecteplase n=74 participants at risk For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase	Placebo n=75 participants at risk For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
Infections and infestations Bacteraemia	0.00% 0/74 • The AEs/SAEs were recorded through the completion of Visit 4. Safety-evaluable population. SAEs of hypoclycemia and convulsion occurred in the placebo group after treatment with open-label tenecteplase. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	1.3% 1/75 • The AEs/SAEs were recorded through the completion of Visit 4. Safety-evaluable population. SAEs of hypoclycemia and convulsion occurred in the placebo group after treatment with open-label tenecteplase. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
Infections and infestations Clostridium Difficile Colitis	0.00% 0/74 • The AEs/SAEs were recorded through the completion of Visit 4. Safety-evaluable population. SAEs of hypoclycemia and convulsion occurred in the placebo group after treatment with open-label tenecteplase. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	1.3% 1/75 • The AEs/SAEs were recorded through the completion of Visit 4. Safety-evaluable population. SAEs of hypoclycemia and convulsion occurred in the placebo group after treatment with open-label tenecteplase. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
Infections and infestations Pneumonia	0.00% 0/74 • The AEs/SAEs were recorded through the completion of Visit 4. Safety-evaluable population. SAEs of hypoclycemia and convulsion occurred in the placebo group after treatment with open-label tenecteplase. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	1.3% 1/75 • The AEs/SAEs were recorded through the completion of Visit 4. Safety-evaluable population. SAEs of hypoclycemia and convulsion occurred in the placebo group after treatment with open-label tenecteplase. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
Infections and infestations Sepsis	1.4% 1/74 • The AEs/SAEs were recorded through the completion of Visit 4. Safety-evaluable population. SAEs of hypoclycemia and convulsion occurred in the placebo group after treatment with open-label tenecteplase. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/75 • The AEs/SAEs were recorded through the completion of Visit 4. Safety-evaluable population. SAEs of hypoclycemia and convulsion occurred in the placebo group after treatment with open-label tenecteplase. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/74 • The AEs/SAEs were recorded through the completion of Visit 4. Safety-evaluable population. SAEs of hypoclycemia and convulsion occurred in the placebo group after treatment with open-label tenecteplase. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	1.3% 1/75 • The AEs/SAEs were recorded through the completion of Visit 4. Safety-evaluable population. SAEs of hypoclycemia and convulsion occurred in the placebo group after treatment with open-label tenecteplase. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
Nervous system disorders Convulsion	0.00% 0/74 • The AEs/SAEs were recorded through the completion of Visit 4. Safety-evaluable population. SAEs of hypoclycemia and convulsion occurred in the placebo group after treatment with open-label tenecteplase. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	1.3% 1/75 • The AEs/SAEs were recorded through the completion of Visit 4. Safety-evaluable population. SAEs of hypoclycemia and convulsion occurred in the placebo group after treatment with open-label tenecteplase. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.

Other adverse events

Additional Information

Medical Communications

Genentech, Inc.

Phone: 800-821-8590

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER